VENTILATOR-INITIATED PROMPT REGARDING DETECTION OF DOUBLE TRIGGERING DURING VENTILATION

Abstract

This disclosure describes systems and methods for monitoring and evaluating ventilatory parameters, analyzing those parameters and providing useful notifications and recommendations to clinicians. That is, modern ventilators monitor, evaluate, and graphically represent multiple ventilatory parameters. However, many clinicians may not easily recognize data patterns and correlations indicative of certain patient conditions, changes in patient condition, and/or effectiveness of ventilatory treatment. Further, clinicians may not readily determine appropriate ventilatory adjustments that may address certain patient conditions and/or the effectiveness of ventilatory treatment. Specifically, clinicians may not readily detect or recognize the presence of double triggering during ventilation. According to embodiments, a ventilator may be configured to monitor and evaluate diverse ventilatory parameters to detect double triggering and may issue notifications and recommendations suitable for a patient to the clinician when double triggering is implicated. The suitable notifications and recommendations may further be provided in a hierarchical format.

Description

INTRODUCTION

A ventilator is a device that mechanically helps patients breathe by replacing some or all of the muscular effort required to inflate and deflate the lungs. In recent years, there has been an accelerated trend towards an integrated clinical environment. That is, medical devices are becoming increasingly integrated with communication, computing, and control technologies. As a result, modern ventilatory equipment has become increasingly complex, providing for detection and evaluation of a myriad of ventilatory parameters. However, due to the shear magnitude of available ventilatory data, many clinicians may not readily assess and evaluate the diverse ventilatory data to detect certain patient conditions and/or changes in patient conditions, such as double triggering. Double triggering is a term that refers to a set of instances in which a ventilator delivers two breaths in response to what is, in fact, a single patient effort. For example, hyperinflation, barotrauma, and/or asynchrony are dangerous conditions that may be implicated/caused by double triggering.

Indeed, clinicians and patients may greatly benefit from ventilator notifications when evaluation of various ventilatory data is indicative of certain patient conditions, changes in patient conditions, effectiveness of ventilatory therapy, or otherwise.

VENTILATOR-INITIATED PROMPT REGARDING DETECTION OF DOUBLE TRIGGERING DURING VENTILATION OF A PATIENT

This disclosure describes systems and methods for monitoring and evaluating ventilatory parameters, analyzing ventilatory data associated with those parameters, and providing useful notifications and/or recommendations to clinicians. Modern ventilators monitor, evaluate, and graphically represent, a myriad of ventilatory parameters. However, many clinicians may not easily identify or recognize data patterns and correlations indicative of certain patient conditions, changes in patient condition, and/or effectiveness of ventilatory treatment. Further, clinicians may not readily determine appropriate ventilatory adjustments that may address certain patient conditions and/or the effectiveness of ventilatory treatment. Specifically, clinicians may not readily detect or recognize the presence of double triggering. According to embodiments, a ventilator may be configured to monitor and evaluate diverse ventilatory parameters to detect double triggering and may issue notifications and recommendations suitable for a patient to the clinician when double triggering is implicated. Double triggering is a term that refers to a set of instances in which a ventilator delivers two breaths in response to what is, in fact, a single patient effort. The suitable notifications and recommendations may further be provided in a hierarchical format such that the clinician may selectively access summarized and/or detailed information regarding the presence of double triggering. In more automated systems, recommendations may be automatically implemented.

According to embodiments, ventilator-implemented methods for detecting double triggering are provided. The methods include collecting data associated with ventilatory parameters and processing the collected ventilatory parameter data, wherein processing the collected ventilatory parameter data includes deriving ventilatory parameter data from the collected ventilatory parameter data. The methods also include analyzing the processed ventilatory parameter data, which includes receiving one or more predetermined thresholds associated with the processed ventilatory parameter data and detecting whether the processed ventilatory parameter data breaches the one or more predetermined thresholds. The methods include determining that double triggering is implicated upon detecting that the processed ventilatory data breaches the one or more predetermined thresholds for more than a percentage of the patient-initiated mandatory breaths (e.g. 10% or 30%) within a predetermined amount of time or that the processed ventilatory data breaches the one or more predetermined thresholds for more than a certain number of breaths (e.g., 3 breaths) within a predetermined amount of time. When double triggering is implicated, the methods include issuing a smart prompt.

According to further embodiments, a ventilatory system for issuing a smart prompt when double triggering is implicated during ventilation of a patient is provided. An appropriate notification message and an appropriate recommendation message may be determined and either or both of the appropriate notification message and the appropriate recommendation message may be displayed.

According to further embodiments, a graphical user interface for displaying one or more smart prompts corresponding to a detected condition is provided. The graphical user interface includes at least one window and one or more elements within the at least one window comprising at least one smart prompt element for communicating information regarding the detected condition, wherein the detected condition is double triggering.

These and various other features as well as advantages which characterize the systems and methods described herein will be apparent from a reading of the following detailed description and a review of the associated drawings. Additional features are set forth in the description which follows, and in part will be apparent from the description, or may he learned by practice of the technology. The benefits and features of the technology will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawing figures, which form a part of this application, are illustrative of described technology and are not meant to limit the scope of the claims in any manner, which scope shall be based on the claims appended hereto.

FIG. 1 is a diagram illustrating an embodiment of an exemplary ventilator connected to a human patient.

FIG. 2 is a block-diagram illustrating an embodiment of a ventilatory system for monitoring and evaluating ventilatory parameters associated with double triggering.

FIG. 3 is a flow chart illustrating an embodiment of a method for detecting an implication of double triggering.

FIG. 4 is a flow chart illustrating an embodiment of a method for issuing a smart prompt upon detecting an implication of double triggering.

FIG. 5 is an illustration of an embodiment of a graphical user interface displaying a smart prompt having a notification message.

FIG. 6 is an illustration of an embodiment of a graphical user interface displaying an expanded smart prompt having a notification message and one or more recommendation messages.

DETAILED DESCRIPTION

Although the techniques introduced above and discussed in detail below may be implemented for a variety of medical devices, the present disclosure will discuss the implementation of these techniques for use in a mechanical ventilator system. The reader will understand that the technology described in the context of a ventilator system could be adapted for use with other therapeutic equipment for alerting and advising clinicians regarding deleted patient conditions.

This disclosure describes systems and methods for monitoring and evaluating ventilatory parameters, analyzing ventilatory data associated with those parameters, and providing useful notifications and/or recommendations to clinicians. Modern ventilators monitor, evaluate, and graphically represent a myriad of ventilatory parameters. However, many clinicians may not easily identify or recognize data patterns and correlations indicative of certain patient conditions, changes in patient condition, and/or effectiveness of ventilatory treatment. Further, clinicians may not readily determine appropriate ventilatory adjustments that may address certain patient conditions and/or the effectiveness of ventilatory treatment. Specifically, clinicians may not readily detect or recognize the presence of double triggering during ventilation of a patient.

According to embodiments, a ventilator may be configured to monitor and evaluate diverse ventilatory parameters to detect double triggering and may issue suitable notifications and recommendations to the clinician when double triggering is implicated. The suitable notifications and recommendations may further be provided in a hierarchical format such that the clinician may selectively access summarized and/or detailed information, regarding the presence of double triggering. In more automated systems, recommendations may he automatically implemented.

Ventilator System

FIG. 1 is a diagram illustrating an embodiment of an exemplary ventilator 100 connected to a human patient 150. Ventilator 100 includes a pneumatic system 102 (also referred to as a pressure generating system 102) for circulating breathing gases to and from patient 150 via the ventilation tubing system 130, which couples the patient 150 to the pneumatic system 102 via an invasive (e.g., endotracheal tube, as shown) or a non-invasive (e.g., nasal mask) patient interface 180.

Ventilation tubing system 130 (or patient circuit 130) may be a two-limb (shown) or a one-limb circuit for carrying gases to and from the patient 150. In a two-limb embodiment, a fitting, typically referred to as a “wye-fitting” 170, may be provided to couple a patient interface 180 (as shown, an endotracheal tube) to an inspiratory limb 132 and an expiratory limb 134 of the ventilation tubing system 130.

Pneumatic system 102 may be configured in a variety of ways. In the present example, pneumatic system 102 includes an expiratory module 108 coupled with the expiratory limb 134 and an inspiratory module 104 coupled with the inspiratory limb 132. Compressor 106 or other source(s) of pressurized gases (e.g., air, oxygen, and/or helium) is coupled with inspiratory module 104 to provide a gas source for ventilatory support via inspiratory limb 132.

The pneumatic system 102 may include a variety of other components, including mixing modules, valves, sensors, tubing, accumulators, filters, etc. Controller 110 is operaratively coupled with pneumatic system 102, signal measurement and acquisition systems, and an operator interlace 120 that may enable an operator to interact with the ventilator 100 (e.g., change ventilator settings, select operational modes, breath types, view monitored parameters, etc). Controller 110 may include memory 112, one or more processors 116, storage 114, and/or other components of the type commonly found in command and control computing devices. In the depleted example, operator interlace 120 includes a display 122 that may be touch-sensitive and/or voice-activated, enabling the display 122 to serve both as an input and output device.

The memory 112 includes non-transitory, computer-readable storage media that stores software that is executed by the processor 116 and which controls the operation of the ventilator 100. In an embodiment, the memory 112 includes one or more solid-state storage devices such as flash memory chips. In an alternative embodiment, the memory 112 may be mass storage connected to the processor 116 through a mass storage controller (not shown) and a communications bus (not shown). Although the description of computer-readable media contained herein refers to a solid-state storage, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 116. That is, computer-readable storage media includes non-transitory, volatile and non-volatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. For example, computer-readable storage media includes RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by the computer.

Communication between components of the ventilatory system or between the ventilatory system and other therapeutic-equipment and/or remote monitoring systems may be conducted over a distributed network, as described further herein, via wired or wireless means. Further, the present methods may be configured as a presentation layer built over the TCP/IP protocol. TCP/IP stands for “Transmission Control Protocol/Internet Protocol” and provides a basic communication language for many local networks (such as intranets or extranets) and is the primary communication language for the Internet. Specifically, TCP/IP is a bi-layer protocol that allow for the transmission of data over a network. The higher layer, or TCP layer, divides a message into smaller packets, which are reassembled by a receiving TCP layer into the original message. The lower layer, or IP layer, handles addressing and routing of packets so that they are properly received at a destination.

Ventilator Components

FIG. 2 is a block-diagram illustrating an embodiment of a ventilatory system 200 for monitoring and evaluating ventilatory parameters associated with double triggering.

Ventilatory system 200 includes a ventilator 202 with its various modules and components. That is, ventilator 202 may further include, inter alia, memory 208, one or more processors 206, user interface 210, and ventilation module 212 (which may further include an inspiration module 214 and ventilation module 216). Memory 208 is defined as described above for memory 112. Similarly, the one or more processors 206 are defined as described above for one or more processors 116. Processors 206 may further be configured with a clock whereby elapsed time may be monitored by the ventilatory system 200.

The ventilatory system 200 may also include a display module 204 communicatively coupled to ventilator 202. Display module 204 provides various input screens, for receiving clinician input, and various display screens, for presenting useful information to the clinician. The display module 204 is configured to communicate with user interface 210 and may include a graphical user interface (GUI). The GUI may be an interactive display, e.g., a touch-sensitive screen or otherwise, and may provide various windows and elements for receiving input and interface command operations. Alternatively, other suitable means of communication with the ventilator 202 may be provided, for instance by a wheel, keyboard, mouse, or other suitable interactive device. Thus, user interface 210 may accept commands and input through display module 204. Display module 204 may also provide useful information in the form of various ventilatory data regarding the physical condition of a patient and/or a prescribed respiratory treatment. The useful information may be derived by the ventilator 202, based on data collected by a data processing module 222, and the useful information may be displayed to the clinician in the form of graphs, wave representations, pie graphs, or other suitable forms of graphic display. For example, one or more smart prompts may be displayed on the GUI and/or display module 204 upon detection of an implication of double triggering by the ventilator. Additionally or alternatively, one or more smart prompts may be communicated to a remote monitoring system, coupled via any suitable means to the ventilatory system 200.

Equation of Motion

Ventilation module 212 may oversee ventilation of a patient according to prescribed ventilatory settings. By way of general overview, the basic elements impacting ventilation may be described by the following ventilatory equation (also known as the Equation of Motion):

P_m+P_v=V_T/C+R*F

Here, P_m is a measure of muscular effort that is equivalent to the pressure generated by the muscles of a patient. If the patient's muscles are inactive, the P_m is equivalent to 0 cm H₂O. During inspiration, P_v represents the positive pressure delivered by a ventilator (generally in cm H₂O). V_T represents the tidal volume delivered, C refers to the respiratory compliance, R represents the respiratory resistance, and F represents the gas flow during inspiration (generally in liters per min (L/m)). Alternatively, during exhalation, the Equation of Motion may be represented as:

P_a+P_t=V_TE/C+R*F

Here, P_a represents the positive pressure existing in the lungs (generally in cm H₂O), P_t represents the transairway pressure, V_TE represents the tidal volume exhaled, C refers to the respiratory compliance, R represents the respiratory resistance, and F represents the gas flow during exhalation (generally in liters per min (L/m)).

Pressure

For positive pressure ventilation, pressure at the upper airway opening (e.g., in the patient's mouth) is positive relative to the pressure at the body's surface (i.e., relative to the ambient atmospheric pressure to which the patient's body surface is exposed, about 0 cm H₂O). As such, when P_t is zero, i.e., no ventilatory pressure is being delivered, the upper airway opening pressure will be equal to the ambient pressure (i.e., about 0 cm H₂O). However, when ventilatory pressure is applied, a pressure gradient is created that allows gases to flow into the airway and ultimately into the lungs of a patient during inspiration (or inhalation).

According to embodiments, additional pressure measurements may be obtained and evaluated. For example, transairway pressure, P_t, which refers to the pressure differential or gradient between the upper airway opening and the alveoli, may also be determined. P_t may be represented mathematically as:

P_t=P_awo−P_a

Where P_awo refers to the pressure in the upper airway opening, or mouth, and P_a refers to the pressure within the alveolar space, or the lungs (as described above). P_t may also be represented as follows:

P_t=F*R

Where F refers to low and R refers to respiratory resistances, as described below.

Additionally, lung pressure or alveolar pressure, P_a may be measured or derived. For example, P_a may be measured via a distal pressure transducer or other sensor near the lungs and/or the diaphragm. Alternatively, P_a may be estimated by measuring the plateau pressure, P_Plat, via a proximal pressure transducer or other sensor at or near the airway opening. Plateau pressure, P_Plat, refers to a slight plateau in pressure that is observed at the end of inspiration when inspiration is held for a period of time, sometimes referred to as an inspiratory hold or pause maneuver, or a breath-hold maneuver. That is, when inspiration is held, pressure inside the alveoli and mouth are equal (i.e., no gas flow). However, as a result of muscular relaxation and elastance of the lungs during the hold period, forces are exerted on the inflated lungs that create a positive pressure. This positive pressure is observed as a plateau in the pressure waveform that is slightly below the peak inspiratory pressure, P_Peak, prior to initiation of exhalation. As may be appreciated, for accurate measurement of P_Plat, the patient should be sedated or non-spontaneous (as muscular effort during the inspiratory pause may skew the pressure measurement). Upon determining P_Plat based on the pressure waveform or otherwise, P_Plat may be used as an estimate of P_a (alveolar pressure).

Flow and Volume

Volume refers to the amount of gas delivered to a patient's lungs, usually in liters (L). Flow refers to a rate of change in volume over time (F=ΔV/ΔT). Flow is generally expressed in liters per minute (L/m or lpm) and, depending on whether gases are flowing into or out of the lungs, flow may be referred to as inspiratory flow or expiratory flow, respectively. According to embodiments, the ventilator may control the rate of delivery of gases to the patient, i.e., inspiratory flow, and may control the rate of release of gases from the patient, i.e., expiratory flow.

As may be appreciated, volume and flow are closely related. That is, where flow is known or regulated, volume may be derived based on elapsed time. Indeed, volume may be derived by integrating the flow waveform. According to embodiments, a tidal volume, V_T, may be delivered upon reaching a set inspiratory time (T_I) at set inspiratory flow. Alternatively, set V_T and set inspiratory flow may determine the amount of time repaired for inspiration, i.e., T_I.

Respiratory Compliance

Additional ventilatory parameters that may be measured and/or derived may include respiratory compliance and respiratory resistance, which refer to the load against which the patient and/or the ventilator must work to deliver gases to the lungs. Respiratory compliance may be interchangeably referred to herein as compliance. Generally compliance refers to a relative ease with which something distends and is the inverse of elastance, which refers to the tendency of something to return to its original form after being deformed. As related to ventilation, compliance refers to the lung volume achieved for a given amount of delivered pressure (C=ΔV/ΔP). Increased compliance may be detected when the ventilator measures an increased volume relative to the given amount of delivered pressure. Some lung diseases (e.g., acute respiratory distress syndrome (ARDS)) may decrease compliance and, thus, require increased pressure to inflate the lungs. Alternatively, other lung diseases may increase compliance, e.g., emphysema, and may require less pressure to inflate the lungs.

Additionally or alternatively, static compliance and dynamic compliance may be calculated. Static compliance, C_S, represents compliance impacted by elastic recoil at zero flow (e.g., of the chest wall, patient circuit, and alveoli). As elastic recoil of the chest wall and patient circuit may remain relatively constant, static compliance may generally represent compliance as affected by elastic recoil of the alveoli. As described above, P_Plat refers to a slight plateau in pressure that is observed after relaxation of pleural muscles and elastic recoil, i.e., representing pressure delivered to overcome elastic forces. As such, P_Plat provides a basis for estimating C_S as follows:

C_S=V_T/(P_Plat−EEP)

Where V_T refers to tidal volume, P_Plat refers to plateau pressure, and EEP refers to end-expiratory pressure, or baseline pressure (including PEEP and/or Auto-PEEP). Note that proper calculation of C_S depends on accurate measurement V_T and P_Plat.

Dynamic compliance, C_D is measured during airflow and, as such, is impacted by both elastic recoil and airway resistance. Peak inspiratory pressure, P_Peak, which represents the highest pressure measured during inspiration, i.e., pressure delivered to overcome both elastic and resistive forces to inflate the lungs, is used to calculate C_D as follows:

C_D=V_T/(P_Peak−EEP)

Where V_T refers to tidal volume, P_Peak refers to peak inspiratory pressure, and EEP refers to end-expiratory pressure. According to embodiments, ventilatory data may be more readily available for trending compliance of non-triggering patients than of triggering patients.

Respiratory Resistance

Respiratory resistance refers to frictional forces that resist airflow, e.g., due to synthetic structures (e.g., endotracheal tube, expiratory valve, etc.), anatomical structures (e.g., bronchial tree, esophagus, etc.), or viscous tissues of the lungs and adjacent organs. Respiratory resistance may be interchangeably referred to herein as resistance. Resistance is highly dependant on the diameter of the airway. That is, a larger airway diameter entails less resistance and a higher concomitant flow. Alternatively, a smaller airway diameter entails higher resistance and a lower concomitant flow. In fact, decreasing the diameter of the airway results in an exponential increase in resistance (e.g., two-times reduction of diameter increases resistance by sixteen times). As may be appreciated, resistance may also increase due to a restriction of the airway that is the result of, inter alia, increased secretions, bronchial edema, mucous plugs, brochospasm, and/or kinking of the patient interface (e.g., invasive endotracheal or tracheostomy tubes).

Airway resistance may further be represented mathematically as:

R=P_t/F

Where P_t refers to the transairway pressure and F refers to the flow. That is, P_t refers to the pressure necessary to overcome resistive forces of the airway. Resistance may be expressed in centimeters of water per liter per second (i.e., cm H₂O/L/s).

Pulmonary Time Constant

As discussed above, compliance refers to the lung volume achieved for a given amount of delivered pressure (C=ΔV/ΔP). That is, stated differently, volume delivered is equivalent to the compliance multiplied by the delivered pressure (ΔV=C*ΔP). However, as the lungs are not perfectly elastic, a period of time is needed to deliver the volume ΔV at pressure ΔP. A pulmonary time constant τ, may represent a time necessary to inflate or exhale a given percentage of the volume at delivered pressure ΔP. The pulmonary time constant, τ, may be calculated by multiplying the respiratory resistance by the respiratory compliance (τ=R*C) for a given patient and τ is generally represented in seconds, s. The pulmonary time constant associated with exhalation of the given percentage of volume may be termed an expiratory time constant and the pulmonary time constant associated with inhalation of the given percentage of volume may be termed an inspiratory time constant.

According to some embodiments, when expiratory resistance data is available, the pulmonary time constant may be calculated by multiplying expiratory resistance by compliance. According to alternative embodiments, the pulmonary time constant may be calculated based on inspiratory resistance and compliance. According to further embodiments, the expiratory time, T_E, should be equal to or greater than three (3) pulmonary time constants to ensure adequate exhalation. That is, for a triggering patient, T_E (e.g., determined by trending T_E or otherwise) should be equal to or greater than 3 pulmonary time constants. For a non-triggering patient, set RR should yield a T_E that is equal to or greater than 3 pulmonary time constants.

Normal Resistance and Compliance

According to embodiments, normal respiratory resistance and compliance may be determined based on a patient's predicted body weight (PBW) (or ideal body weight (IBW)). That is, according to a standardized protocol or otherwise, patient data may be compiled such that normal respiratory resistance and compliance values and/or ranges of values may be determined and provided to the ventilatory system 200. That is, a manufacturer, clinical facility, clinician, or otherwise, may configure the ventilator with normal respiratory resistance and compliance values and/or ranges of values based on PBWs (or IBWs) of a patient population. Thereafter, during ventilation of a particular patient, respiratory resistance and compliance data may be trended for the patient and compared to normal values and/or ranges of values based on the particular patient's PBW (or IBW). According to embodiments, the ventilator may give an indication to the clinician regarding whether the trended respiratory resistance and compliance data of the particular patient falls into normal ranges. According to some embodiments, data may be more readily available for trending resistance and compliance for non-triggering patients than for triggering patients.

According to further embodiments, a predicted T_E may be determined based on a patient's PBW (or IBW). That is, according to a standardized protocol, or otherwise, patient population data may be compiled such that predicted T_E values and/or ranges of values may be determined based on PBWs (or IBWs) of the patient population and provided to the ventilatory system 200. Actual (or trended) T_E for a particular patient may then be compared to the predicted T_E. As noted previously, increased resistance and/or compliance may result in an actual T_E that is longer than predicted T_E. However, when actual T_E is consistent with predicted T_E, this may indicate that resistance and compliance for the particular patient fall into normal ranges.

According to further embodiments, a normal pulmonary time constant, τ, may be determined based on a patient's PBW (or IBW). That is, according to a standardized protocol or otherwise, patient data may be compiled such that normal τ values and/or ranges of values may be determined based on PBWs (or IBWs) of a patient population and provided to the ventilatory system 200. A calculated τ may be determined for a particular patient by multiplying resistance by compliance (as described above, resistance and compliance data may be more readily available for a non-triggering patient). As the product of resistance and compliance results in τ, increased resistance and/or compliance may result in an elevated τ value. However, when the calculated τ value for the particular patient is consistent with the normal τ value, this may indicate that the resistance and compliance of the particular patient fall into normal ranges.

Inspiration

Ventilation module 212 may further include an inspiration module 214 configured to deliver gases to the patient according to prescribed ventilatory settings. Specifically, inspiration module 214 may correspond to the inspiratory module 104 or may be otherwise coupled to source(s) of pressurized gases (e.g., air, oxygen, and/or helium), and may deliver gases to the patient. Inspiration module 214 may be configured to provide ventilation according to various ventilatory breath types, e.g., via volume-targeted, pressure-targeted, or via any other suitable breath types.

Volume ventilation, refers to various forms of volume-targeted ventilation that regulate volume delivery to the patient. Different types of volume ventilation are available depending on the specific implementation of volume regulation, for example, for volume-cycled ventilation, an end of inspiration is determined based on monitoring the volume delivered to the patient. Volume ventilation may include volume-control (VC), volume-targeted-pressure-control (VC+), or volume-support (VS) breath types. Volume ventilation may be accomplished by setting a target volume, or prescribed tidal volume, V_T, for delivery to the patient. According to embodiments, prescribed V_T and inspiratory time (T_I) may be set during ventilation start-up, based on the patient's PBW (or IBW). In this case, flow will be dependent on the prescribed V_T and set T_I. Alternatively, prescribed V_T and flow may be set and T_I may result. According to some embodiments, a predicted T_E may be determined based on normal respiratory and compliance values or value ranges based on the patient's PBW (or IBW), Additionally, a respiratory rate (RR) setting, generally in breaths/min, may be determined and configured. For a non-triggering patient, the set RR controls the timing for each inspiration. For a triggering patient, the RR setting applies if the patient stops triggering for some reason and/or the patient's triggered RR drops below a threshold level.

According to embodiments, during volume ventilation, as volume and flow are regulated by the ventilator, delivered V_T, flow waveforms (or flow traces), and volume waveforms may be constant and may not be affected by variations in lung or airway characteristics (e.g., respiratory compliance and/or respiratory resistance). Alternatively, pressure readings may fluctuate based on lung or airway characteristics. According to some embodiments, the ventilator may control the inspiratory flow and then derive volume based on the inspiratory flow and elapsed time. For volume-cycled ventilation, when the derived volume is equal to the prescribed V_T, the ventilator may initiate exhalation.

According to alternative embodiments, the inspiration module 214 may provide ventilation via a form of pressure ventilation. Pressure-targeted breath types may he provided by regulating the pressure delivered to the patient in various ways. For example, during pressure-cycled ventilation, an end of inspiration is determined based on monitoring the pressure delivered to the patient. Pressure ventilation may include a pressure-support (PS), a proportional assist (PA), or a pressure-control (PC) breath type, for example. The proportional assist (PA) breath type provides pressure in proportion, to the instantaneous patient effort during spontaneous ventilation and is base on the equation of motion. Pressure ventilation may also include various forms of bi-level (BL) pressure ventilation, i.e., pressure ventilation in which the inspiratory positive airway pressure (IPAP) is higher than the expiratory positive airway pressure (EPAP). Specifically, pressure ventilation may be accomplished by setting a target or prescribed pressure for delivery to the patient. During pressure ventilation, predicted T_I may be determined based on normal respiratory and compliance values and on the patient's PBW (or IBW). According to some embodiments, a predicted T_E may be determined based on normal respiratory and compliance values and based on the patient's PBW (or IBW). A respiratory rate (RR) setting may also be determined and configured. For a non-triggering patient, the set RR controls the timing for each inspiration. For a triggering patient, the RR setting applies if the patient stops triggering for some reason and/or patient triggering drops below a threshold RR level.

According to embodiments, during pressure ventilation, the ventilator may maintain the same pressure waveform at the month, P_awo, regardless of variations in lung or airway characteristics, e.g., respiratory compliance and/or respiratory resistance. However, the volume and flow waveforms may fluctuate based on lung and airway characteristics. As noted above, pressure delivered to the upper airway creates a pressure gradient that enables gases to flow into a patient's lungs. The pressure from which a ventilator initiates inspiration is termed the end-expiratory pressure (EEP) or “baseline” pressure. This pressure may be atmospheric pressure (about 0 cm H₂O), also referred to zero end-expiratory pressure (ZEEP). However, commonly, the baseline pressure may be positive, termed positive end-expiratory pressure (PEEP). Among other things, PEEP may promote higher oxygenation saturation and/or may prevent alveolar collapse during exhalation. Under pressure-cycled ventilation, upon delivering the prescribed pressure the ventilator may initiate exhalation.

According to still other embodiments, a combination of volume and pressure ventilation may be delivered to a patient, e.g., volume-targeted-pressure-control (VC+) breath type. In particular, VC+ may provide benefits of setting a target V_T, while also allowing for monitoring variations in flow. As will be detailed further below, variations in flow may be indicative of various patient conditions.

Exhalation

Ventilation module 212 may further include an exhalation module 216 configured to release gases from the patient's lungs according to prescribed ventilatory settings. Specifically, exhalation module 216 may correspond to expiratory module 108 or may otherwise be associated with and/or controlling an expiratory valve for releasing gases from the patient. By way of general overview, a ventilator may initiate exhalation based on lapse of an inspiratory time setting (T_I) or other cycling criteria set by the clinician or derived from ventilator settings (e.g., detecting delivery of prescribed V_T or prescribed pressure based on a reference trajectory). Upon initiating the expiratory phases exhalation module 216 may allow the patient to exhale by opening an expiratory valve. As such, exhalation is passive, and the direction of airflow, as described above, is governed by the pressure gradient between the patient's lungs (higher pressure) and the ambient surface pressure (lower pressure). Although expiratory flow is passive, it may be regulated by the ventilator based on the size of the expiratory valve opening.

Expiratory time (T_E) is the time from the end of inspiration until the patient triggers for a spontaneously breathing patient. For a non-triggering patient, it is the time from the end of inspiration until the next inspiration based on the set RR. In some cases, however, the time required to return to the functional residual capacity (FRC) or resting capacity of the lungs is longer than provided by T_E (e.g., because the patient triggers prior to fully exhaling or the set RR is too high for a non-triggering patient). According to embodiments, various ventilatory settings may be adjusted to better match the time to reach FRC with the time available to reach FRC. For example, increasing flow will shorten T_I, thereby increasing the amount of time available to reach FRC. Alternatively, V_T may be decreased, resulting in less time required to reach FRC,

As may be further appreciated, at the point of transition between inspiration and exhalation, the direction of airflow may abruptly change from flowing into the lungs to flowing out of the lungs or vice versa depending on the transition. Stated another way, inspiratory flow may be measurable in the ventilatory circuit until P_Peak is reached, at which point flow is zero. thereafter, upon initiation of exhalation, expiratory flow is measurable in the ventilatory circuit until the pressure gradient between the lungs and the body's surface reaches zero (again, resulting in zero flow). However, in some cases, as will be described further herein, expiratory flow may still be positive, i.e., measurable, at the end of exhalation (termed positive end-expiratory flow or positive EEF). In this case, positive EEF is an indication that the pressure gradient has not reached zero or, similarly, that the patient has not completely exhaled. Although a single occurrence of premature inspiration may not warrant concern, repeated detection of positive EEF may be indicative of Auto-PEEP.

Ventilator Synchrony and Patient Triggering

According to some embodiments, the inspiration module 214 and/or the exhalation module 216 may be configured to synchronize ventilation with a spontaneously-breathing, or triggering, patient. That is, the ventilator may be configured to detect patient effort and may initiate a transition from exhalation to inspiration (or from inspiration to exhalation) in response. Triggering refers to the transition from exhalation to inspiration in order to distinguish it from the transition from inspiration to exhalation (referred to as cycling). Ventilation systems, depending on their breath type, may trigger and/or cycle automatically, or in response to a detection of patient effort, or both.

Specifically, the ventilator may detect patient effort via a pressure-monitoring method, a flow-monitoring method, direct or indirect measurement of nerve impulses, or any other suitable method. Sensing devices may be either internal or distributed and may include any suitable sensing device, as described further herein. In addition, the sensitivity of the ventilator to changes in pressure and/or flow may be adjusted such that the ventilator may properly detect the patient effort, i.e., the lower the pressure or flow change setting the more sensitive the ventilator may be to patient triggering.

According to embodiments, a pressure-triggering method may involve the ventilator monitoring the circuit pressure, as described above, and detecting a slight drop in circuit pressure. The slight drop in circuit pressure may indicate that the patient's respiratory muscles, P_m, are creating a slight negative pressure gradient between the patient's lungs and the airway opening in an effort to inspire. The ventilator may interpret the slight drop in circuit pressure as patient effort and may consequently initiate inspiration by delivering respiratory gases.

Alternatively, the ventilator may detect a flow-triggered event. Specifically, the ventilator may monitor the circuit flow, as described above. If the ventilator detects a slight drop in flow during exhalation, this may indicate, again, that the patient is attempting to inspire. In this case, the ventilator is detecting a drop in bias flow (or baseline flow) attributable to a slight redirection of gases into the patient's lungs (in response to a slightly negative pressure gradient as discussed above). Bias flow refers to a constant flow existing in the circuit during exhalation that enables the ventilator to detect expiratory flow changes and patient triggering. For example, while gases are generally flowing out of the patient's lungs during exhalation, a drop in flow may occur as some gas is redirected and flows into the lungs in response to the slightly negative pressure gradient between the patient's lungs and the body's surface. Thus, when the ventilator detects a slight drop in flow below the bias flow by a predetermined threshold amount (e.g., 2 L/min below bias flow), it may interpret the drop as a patient trigger and may consequently initiate inspiration by delivering respiratory gases.

Volume-Control Breath Type

In some embodiments, ventilation module 212 may further include an inspiration module 214 configured to deliver gases to the patient according to volume-control (VC). The VC breath type allows a clinician to set a respiratory rate and to select a volume to be administered to a patient during a mandatory breath. When using VC, a clinician sets a desired tidal volume, flow wave form shape, and an inspiratory flow rate or inspiratory time. These variables determine how much volume of gas is delivered to the patient and the duration of inspiration during each mandatory breath inspiratory phase. The mandatory breaths are administered according to the set respiratory rate.

For VC, when the delivered volume is equal to the prescribed tidal volume, the ventilator may initiate exhalation. Exhalation lasts from the time at which prescribed volume is reached until the start of the next ventilator mandated inspiration. This expiration time is determined by the respiratory rate set by the clinician and any participation above the set rate by the patient. Upon the end of exhalation, another VC mandatory breath is given to the patient.

During VC, delivered volume and flow waveforms may remain constant and may not be affected by variations in lung or airway characteristics. Alternatively, pressure readings may fluctuate based on lung or airway characteristics. According to some embodiments, the ventilator may control the inspiratory flow and then derive volume based on the inspiratory flow and elapsed time.

In some embodiments, VC may also be delivered to a triggering patient. When VC is delivered to a triggering patient, the breath period (i.e. time between breaths) is a function of the frequency at which the patient is triggering breaths. That is, the ventilator will trigger the inhalation based upon the respiratory rate setting or the patient effort. If no patient effort is detected, the ventilator will deliver another mandatory breath at the predetermined respiratory rate.

Volume-Targeted-Pressure-Control Breath Type

In further embodiments, ventilation module 212 may further include an inspiration module 214 configured to deliver gases to the patient using a volume-targeted-pressure-control (VC+) breath type. The VC+ breath type is a combination of volume and pressure control breath types that may be delivered to a patient as a mandatory breath. In particular, VC+ may provide the benefits associated with setting a target tidal volume, while also allowing for variable flow. Variable flow may he helpful in meeting inspiratory flow demands for actively breathing patients.

As may be appreciated, when resistance increases it becomes more difficult to pass gases into and out of the lungs, decreasing flow. For example, when a patient is intubated, i.e., having either an endotracheal or a tracheostomy tube in place, resistance may be increased as a result of the smaller diameter of the tube over a patient's natural airway. In addition, increased resistance may be observed in patients with obstructive disorders, such as COPD, asthma, etc. Higher resistance may necessitate, inter alia, a higher inspiratory time setting for delivering a prescribed pressure or volume of gases, a lower respiratory rate resulting in a higher expiratory time for complete exhalation of gases.

Unlike VC, when the set inspiratory time is reached, the ventilator may initiate expiration. Expiration lasts from the end of inspiration until the beginning of the next inspiration. For a non-triggering patient, the expiratory time (T_E) is based on the respiratory rate set by the clinician. Upon the end of expiration, another VC+ mandatory breath is given to the patient.

By controlling target tidal volume and allowing for variable flow, VC+ allows a clinician to maintain the volume while allowing the flow and pressure targets to fluctuate.

Volume-Support Breath Type

In some embodiments, ventilation module 212 may further include an inspiration module 214 configured to deliver gases to the patient according to volume-support (VS) breath type. The VS breath type is utilized in the present disclosure as a spontaneous breath. VS is generally used with a triggering (spontaneously breathing) patient when the patient is ready to be weaned from a ventilator or when the patient cannot do all of the work of breathing on his or her own. When the ventilator senses patient inspiratory effort, the ventilator delivers a set tidal volume during inspiration. The tidal volume may be set and adjusted by the clinician. The patient controls the rate, inspiratory flow, and has some control over the inspiratory time. The ventilator then adjusts the pressure over several breaths to achieve the set tidal volume. When the machine senses a decrease in flow, or inspiration time reaches a predetermined limit, the ventilator determines that inspiration is ending. When delivered as a spontaneous breath, expiration in VS lasts from a determination that inspiration is ending until the ventilator senses a next patient effort to breath.

Pressure-Control Breath Type

In additional embodiments, ventilation module 212 may further include an inspiration module 214 configured to deliver gases to the patient according to the pressure-control (PC) breath type. PC allows a clinician to select a pressure to be administered to a patient during a mandatory breath. When using the PC breath type, a clinician sets a desired pressure, inspiratory time, and respiratory rate for a patient. These variables determine the pressure of the gas delivered to the patient during each mandatory breath inspiration. The mandatory breaths are administered according to the set respiratory rate.

For the PC breath type, when the inspiratory time is equal to the prescribed inspiratory time, the ventilator may initiate expiration. Expiration lasts from the end of inspiration until the next inspiration. Upon the end of expiration, another PC mandatory breath is given to the patient.

During PC breaths, the ventilator may maintain the same pressure waveform at the mouth, regardless of variations in lung or airway characteristics, e.g., respiratory compliance and/or respiratory resistance. However, the volume and low waveforms may fluctuate based on lung and airway characteristics.

In some embodiments, PC may also be delivered for triggering patients. When PC is delivered with triggering, the breath period (i.e., time between breaths) is a function of the respiratory rate of the patient. The ventilator will trigger the inhalation based upon the respiratory rate setting or the patient's trigger effort, but cycling to exhalation will be based upon elapsed inspiratory time. The inspiratory time is set by the clinician. The inspiratory flow is delivered based upon the pressure setting and patient physiology. Should the patient create air expiratory effort in the middle of the mandatory inspiratory phase, the ventilator will respond by reducing flow. If no patient effort is detected, the ventilator will deliver another mandatory breath at the predetermined respiratory rate.

PC with triggering overcomes some of the problems encountered by other mandatory breath types that use artificially set inspiratory flow rates. For example, if the inspiratory flow is artificially set lower than a patient's demand, the patient will feel starved for flow. This can lead to undesirable effects, including increased work of breathing. In addition, should the patient begin to exhale when using one of the traditional mandatory breath types, the patient's expiratory effort is ignored since the inspiratory flow is mandated by the ventilator settings.

Pressure-Support Breath Type

In further embodiments, ventilation module 212 may further include an inspiration module 214 configured to deliver gases to the patient according to a pressure-support (PS) breath type. PS is a form of assisted ventilation and is utilized in the present disclosure during a spontaneous breath. PS is a patient triggered breath and is typically used when a patient is ready to be weaned from a ventilator or for when patients are breathing spontaneously but cannot do all the work of breathing on their own. When the ventilator senses patient inspiratory effort, the ventilator provides a constant pressure during inspiration. The pressure may be set and adjusted by the clinician. The patient controls the rate, inspiratory flow, and to an extent, the inspiratory time. The ventilator delivers the set pressure and allows the flow to vary. When the machine senses a decrease in flow, or determines that inspiratory time has reached a predetermined limit, the ventilator determines that inspiration is ending. When delivered as a spontaneous breath, expiration in PS lasts from a determination that inspiration is ending until the ventilator senses a patient effort to breath.

Expiratory Sensitivity

As discussed above, ventilation module 212 may oversee ventilation of a patient according to prescribed ventilatory settings. In one embodiment, the expiratory sensitivity (E_SENS) is set by a clinician or operator. According to embodiments, E_SENS sets the percentage of delivered peak inspiratory flow necessary to terminate inspiration and initiate exhalation. In some embodiments, the clinician operator determines the E_SENS setting, which is adjustable from 1% to 80%. A lower set E_SENS increases inspiration time and a higher set E_SENS decreases inspiration time. The E_SENS setting may be utilized to limit unnecessary expiratory work and to improve patient-ventilator synchrony.

The ventilatory system 200 may also include one or mote distributed sensors 218 communicatively coupled to ventilator 202. Distributed sensors 218 may communicate with various components of ventilator 202, e.g., ventilation module 212, internal sensors 220, data processing module 222, double triggering detection module 224, and any other suitable components and/or modules. Distributed sensors 218 may detect changes in ventilatory parameters indicative of double triggering, for example. Distributed sensors 218 may be placed in any suitable location, e.g., within the ventilatory circuitry or other devices communicatively coupled to the ventilator. For example, sensors may be affixed to the ventilatory tubing or may be imbedded in the tubing itself. According to some embodiments, sensors may be provided at or near the lungs (or diaphragm) for detecting a pressure in the lungs. Additionally or alternatively, sensors may be affixed or imbedded in or near wye-fitting 170 and/or patient interface 180, as described above.

Distributed sensors 218 may further include pressure transducers that may detect changes in circuit pressure (e.g., electromechanical transducers including piezoelectric, variable capacitance, or strain gauge). Distributed sensors 218 may further include various flowmeters for detecting airflow (e.g., differential pressure pneumotachometers). For example, some flowmeters may use obstructions to create a pressure decrease corresponding to the flow across the device (e.g., differential pressure pneumotachometers) and other flowmeters may use turbines such that flow may be determined based on the rate of turbine rotation (e.g., turbine flowmeters). Alternatively, sensors may utilize optical or ultrasound techniques for measuring changes in ventilatory parameters. A patient's blood parameters or concentrations of expired gases may also be monitored by sensors to detect physiological changes that may be used as indicators to study physiological effects of ventilation, wherein the results of such studies may be used for diagnostic or therapeutic purposes. Indeed, any distributed sensory device useful for monitoring changes in measurable parameters daring ventilatory treatment may be employed in accordance with embodiments described herein.

Ventilator 202 may farther include one or more internal sensors 220. Similar to distributed sensors 218, internal sensors 220 may communicate with various components of ventilator 202, e.g., ventilation module 212, internal sensors 220, data processing module 222, double triggering detection module 224, and any other suitable components and/or modules. Internal sensors 220 may employ any suitable sensory or derivative technique for monitoring one or more parameters associated with the ventilation of a patient. However, the one or more internal sensors 220 may be placed in any suitable internal location, such as, within the ventilatory circuitry or within components or modules of ventilator 202. For example, sensors may be coupled to the inspiratory and/or expiratory modules for detecting changes in, for example, circuit pressure and/or flow. Specifically, internal sensors 220 may include pressure transducers and flowmeters for measuring changes in circuit pressure and airflow. Additionally or alternatively, internal sensors 220 may utilize optical or ultrasound techniques for measuring changes in ventilatory parameters. For example, a patient's expired gases may be monitored by internal sensors 220 to detect physiological changes indicative of the patient's condition and/or treatment, for example. Indeed, internal sensors 220 may employ any suitable mechanism for monitoring parameters of interest in accordance with embodiments described herein.

As should be appreciated, with reference to the Equation of Motion, ventilatory parameters are highly interrelated and, according to embodiments, may be either directly or indirectly monitored. That is, parameters may be directly monitored by one or more sensors, as described above, or may be indirectly monitored by derivation according to the Equation of Motion.

Ventilatory Data

Ventilator 202 may further include a data processing module 222. As noted above, distributed sensors 218 and internal sensors 220 may collect data regarding various ventilatory parameters. A ventilatory parameter refers to any factor, characteristic, or measurement associated with the ventilation of a patient, whether monitored by the ventilator or by any other device. Sensors may further transmit collected data to the data processing module 222 and, according to embodiments, the data processing module 222 may be configured to collect data regarding some ventilatory parameters, to derive data regarding other ventilatory parameters, and to graphically represent collected and derived data to the clinician and/or other modules of the ventilatory system 200. Some collected, derived, and/or graphically represented data may be indicative of double triggering. For example, data regarding expiratory time, exhaled tidal volume, inspiratory time setting (T_I), etc., may be collected, derived, and/or graphically represented by data processing module 222.

Flow Data

For example, according to embodiments, data processing module 222 may be configured to monitor inspiratory and expiratory flow. Flow may be measured by any appropriate, internal or distributed device or sensor within the ventilatory system 200. As described above, flowmeters may be employed by the ventilatory system 200 to detect circuit flow. However, any suitable device either known or developed in the future may be used for detecting airflow in the ventilatory circuit.

Data processing module 222 may be further configured to plot monitored flow data graphically via any suitable means. For example, according to embodiments, flow data may be plotted versus time (flow waveform), versus volume (flow-volume loop), or versus any other suitable parameter as may be useful to a clinician. According to embodiments, flow may be plotted such that each breath may be independently identified. Further, flow may be plotted such that inspiratory flow and expiratory flow may be independently identified, e.g., inspiratory flow may be represented in one color and expiratory flow may be represented in another color. According to additional embodiments, flow waveforms and flow-volume loops, for example, may be represented alongside additional graphical representations, e.g., representations of volume, pressure, etc., such that clinicians may substantially simultaneously visualize a variety of ventilatory parameters associated with each breath.

As may be appreciated, flow decreases as resistance increases, making it more difficult to pass gases into and out of the lungs (i.e., F=P_t/R). For example, when a patient is intubated, i.e., having either an endotracheal or a tracheostomy tube in place, resistance may be increased as a result of the smaller diameter of the tube over a patient's natural airway. In addition, increased resistance may be observed in patients with obstructive disorders, such as COPD, asthma, etc. Higher resistance may necessitate, inter alia, a higher inspiratory time setting (T_I) for delivering a prescribed pressure or volume of gases, a higher flow setting for delivering prescribed pressure or volume, a lower respiratory rate resulting in a higher expiratory time (T_E) for complete exhalation of gases, etc.

Specifically, changes in flow may be detected by evaluating various flow data. For example, by evaluating FV loops, as described above, an increase in resistance may be detected over a number of breaths. That is, upon comparing consecutive FV loops, the expiratory plot for each FV loop may reflect a progressive reduction in expiratory flow (i.e., a smaller FV loop), indicative of increasing resistance.

Pressure Data

According to embodiments, data processing module 222 may be configured to monitor pressure. Pressure may be measured by any appropriate, internal or distributed device or sensor within the ventilatory system 200. For example, pressure may be monitored by proximal electromechanical transducers connected near the airway opening (e.g., on the inspiratory limb, expiratory limb, attire patient interface, etc.). Alternatively, pressure may be monitored distally, at or near the lungs and/or diaphragm of the patient.

For example, P_Peak and/or P_Plat (estimating P_a) may be measured proximally (e.g., at or near the airway opening) via single-point pressure measurements. According to embodiments, P_Plat (estimating P_a) may be measured during an inspiratory pause maneuver (e.g., expiratory and inspiratory valves are closed briefly at the end of inspiration for measuring the P_Plat at zero flow). According to other embodiments, circuit pressure may be measured during an expiratory pause maneuver (e.g., expiratory and inspiratory valves are closed briefly at the end of exhalation for measuring EEP at zero flow).

Data processing module 222 may be further configured to plot monitored pressure data graphically via any suitable means. For example, according to embodiments, pressure data may be plotted versus time (pressure waveform), versus volume (pressure-volume loop or PV loop), or versus any other suitable parameter as may be useful to a clinician. According to embodiments, pressure may be plotted such that each breath may be independently identified. Further, pressure may be plotted such that inspiratory pressure and expiratory pressure may be independently identified, e.g., inspiratory pressure may be represented in one color and expiratory pressure may be represented in another color. According to additional embodiment, pressure waveforms and PV loops, for example, may be represented alongside additional graphical representations, e.g., representations of volume, flow, etc., such that a clinician may substantially simultaneously visualize a variety of parameters associated with each breath.

According to embodiment, PV loops may provide useful clinical and diagnostic information to clinicians regarding the respiratory resistance or compliance of a patient. Specifically, upon comparing PV loops from successive breaths, an increase in resistance may be detected when successive PV loops shorten and widen over time. That is, at constant pressure, less volume is delivered to the lungs when resistance is increasing, resulting in a shorter, wider PV loop. According to alternative embodiments, a PV loop may provide a visual representation, in the area between the inspiratory plot of pressure vs. volume and the expiratory plot of pressure vs. volume, which is indicative of respiratory compliance. Further, PV loops may be compared to one another to determine whether compliance has changed. Additionally or alternatively, optimal compliance may be determined. That is, optimal compliance may correspond to the dynamic compliance determined from a PV loop during a recruitment maneuver, for example.

According to additional embodiment, PV curves may be used to compare C_S and C_D over a number of breaths. For example, a first PV curve may be plotted for C_S (based on P_Plot less EEP) and a second PV curve may be plotted C_D (based on P_Peak less EEP). Under normal conditions, C_S and C_D curves may be very similar, with the C_D curve mimicking the C_S curve but shifted to the right (i.e., plotted at higher pressure). However, in some cases the C_D curve may flatten out and shift to the right relative to the C_S curve. This graphical representation may illustrate increasing P_t, and thus increasing R, which may be due to mucous plugging or bronchospasm, for example. In other cases, both the C_D curve and C_S curves may flatten out and shift to the right. This graphical representation may illustrate an increase in P_Peak and P_Plat, without an increase in P_t, and thus may implicate a decrease in lung compliance, which may be due to tension pneumothorax, atelectasis, pulmonary edema, pneumonia, bronchial intubation, etc.

As may be further appreciated, relationships between resistance, static compliance, dynamic compliance, and various pressure readings may give indications of patient condition. For example, when C_S increases, C_D increases and, similarly, when R increases, C_D increases. Additionally, as discussed previously, P_t represents the difference in pressure attributable to resistive forces over elastic forces. Thus, where P_Peak and P_t are increasing with constant V_T delivery, R is increasing (i.e., where P_Peak is increasing without a concomitant increase in P_Plat). Where P_t is roughly constant, but where P_Peak and P_Plat and are increasing with a constant V_T delivery, C_S is increasing.

Volume Data

According to embodiments, data processing module 222 may be configured to derive volume via any suitable means. For example, as described above, during volume ventilation, a prescribed V_T may be set for delivery to the patient. The actual volume delivered may be derived by monitoring the inspiratory flow over time (i.e., V=F*T). Stated differently, integration of flow over time will yield volume. According to embodiments, V_T is completely delivered upon reaching T_I. Similarly, the expiratory flow may be monitored such that expired tidal volume (V_TE) may be derived. That is, under ordinary conditions, upon reaching the T_E, the prescribed V_T delivered should be completely exhaled and FRC should be reached. However, under some conditions T_E is inadequate for complete exhalation and FRC is not reached.

Data processing module 222 may be further configured to plot derived volume data graphically via any suitable means. For example, according to embodiments, volume data may be plotted versus time (volume waveform), versus flow (flow-volume loop or FV loop), or versus any other suitable parameter as may be useful to a clinician. According to embodiments, volume may be plotted such that each breath may be independently identified. Further, volume may be plotted such that prescribed V_T and V_TE may be independently identified, e.g., prescribed V_T may be represented in one color and V_TE may be represented in another color. According to additional embodiments, volume waveforms and FV loops, for example, may be represented alongside additional graphical representations, e.g., representations of pressure, flow, etc., such that a clinician may substantially simultaneously visualize a variety of parameters associated with each breath.

According to embodiments, data processing module 233 may be configured to determine if the ventilation tubing system 130 or patient circuit has become disconnected from the patient or the ventilator during ventilation. Data processing module 222 determines that a patient circuit is disconnected by any suitable means. In some embodiments, data processing module 222 determines that the patient circuit is disconnected by evaluating data, such as exhaled pressure and/or exhaled volume. In further embodiments, data processing module 222 determines if the patient circuit is disconnected by determining if a disconnect alarm has been executed. If the disconnect alarm has been executed, then data processing module 222 determines that the patient circuit is disconnected. If the disconnect alarm has not been executed, then data processing module 222 determines that the patient circuit is connected.

Breath Type

According to embodiments, data processing module 232 may be configured to identify the ventilator breath type. Data processing module 222 determines the breath type by any suitable means or methods. In some embodiments, data processing module 222 determines the breath type based on clinician or operator input and/or selection. In further embodiments, data processing module 222 determines the breath type based on ventilator selection of the breath type. For example, some breath, types include VC, PC, VC+, PS, PA, and VS.

Double Trigger Detection

Ventilator 202 may further include a double triggering detection module 224. Double triggering is a term that refers to a set of instances in which a ventilator delivers two breaths in response to what is, in fact, a single patient effort. A double trigger occurs when the ventilator delivers two or more ventilator cycles separated by a very short expiratory time, with at least one breath being triggered by the patient. Typically the first cycle is patient triggered and the second breath is triggered by either a continuation of the patient's inspiratory effort or from some anomalous condition that is interpreted by the ventilator as a second patient effort. Because of the short expiratory time, the additional breaths may come before the patient has the chance to fully exhale and may cause gas-trapping in the lungs. Accordingly, double triggering can lead to patient discomfort and/or an increase in the length of ventilation time. Further, double triggering can lead to hyper inflation, barotraumas, hypoxia, and/or asynchrony.

Barotrauma may result from the over-distension of alveoli, which may cause disruption of the alveolar epithelium. Further as pressure in the alveoli increases, some alveoli may rupture, allowing gases to seep into the perivascular sheath and into the mediastinum. This condition may be referred to as pulmonary interstitial emphysema (PIE). Further complications associated with PIE may result in Pneumothorax (i.e., partial to complete collapse of a lung due to gases collected in the pleural cavity).

Double triggering may result when there is a mismatch between the ventilation setting for inspiratory time and the patient's neurological inspiratory time. The patient's neurological inspiratory time is the amount of time desired by the patient between breaths. The patient neurological inspiratory time may vary for every patient and may vary per breath for each patient. Double triggering may also result when there is mismatch between flow and set inspiratory time and patient desired flow and neurological inspiratory time.

According to embodiments, double triggering may occur as a result of various patient conditions and/or inappropriate ventilator settings. Thus, according to embodiments, double triggering detection module 224 may evaluate various ventilatory parameter data based on one or more predetermined thresholds to detect the presence of double triggering. For example, double triggering detection module 224 may evaluate expiratory time, exhaled tidal volume, inspiratory time setting (T_I), patient circuit connection, etc. and compare the evaluated parameters to one or more predetermined thresholds. In order to prevent unnecessary alarms, prompts, notifications, and/or recommendations, thresholds and conditions are utilized by the double triggering detection module 224 to determine when double triggering has occurred with sufficient frequency to warrant notification of the operator. For example, in some embodiments, a double trigger that occurs in isolation from any other double trigger will not be considered enough to warrant an occurrence of double triggering by the double triggering detection module 224. As used herein any threshold, condition, setting, parameter, or frequency that is “predetermined” may be input or selected by the operator and/or may be set or selected by the ventilator.

In embodiments, the double triggering detection module 224 may detect double triggering when one or more predetermined thresholds are breached at a predetermined frequency. In some embodiments, the double triggering detection module 224 may detect double triggering when one or more predetermined thresholds are breached at least three times within a predetermined amount of time. In alternative embodiments, the double triggering detection module 224 may detect double triggering when one or more predetermined thresholds are breached by more than 30% of the patient-initiated mandatory breaths within a predetermined amount of time. In some embodiments, the double triggering detection module 224 may detect double triggering when one or more predetermined thresholds are breached more than 10% of the patient-initiated mandatory breaths within a predetermined amount of time. The predetermined amount of time may be any suitable range of time for determining if double triggering has occurred, such as any time ranging from 30 seconds to 240 seconds.

According to some embodiments, double triggering detection module 224 may detect double triggering when a double trigger has occurred at least three times within the last 60 seconds. According to further embodiments, double triggering detection module 224 may detect double triggering when more than 30% of the patient-initiated mandatory breaths have a doable trigger within the last 180 seconds. According to additional embodiments, double triggering defection module 224 may detect double triggering when more than 10% of the patient-initiated mandatory breaths have a double trigger within the last 60 seconds. The double triggering detection module 224 may begin the evaluation at the beginning of each patient-initiated breath.

In some embodiments, double triggering detection module 224 detects a double trigger when one or more of the following conditions are met:

• • 1. expiratory time for a patient-initiated mandatory breath is less than 240 milliseconds (ms);
  • 2. the exhaled tidal volume associated with the expiratory period is less than 10% of the delivered tidal volume of the prior inspiratory period; and
  • 3. no disconnect alarm is detected.
    In further embodiments, condition number 1, listed above, may refer to any suitable expiratory time threshold. For example, in an alternative embodiment the expiratory time threshold is an expiratory time of less than 230 ms, 220 ms, 210 ms, 200 ms, or 190 ms depending upon the type of ventilator, patient, breath type, ventilator parameters, ventilator settings, and/or ventilator modes, etc. Condition number 3 listed above, is considered a “threshold” in the present disclosure and in the listed claims. Further, the detection of any yes/no “condition” is considered a “threshold” in the present disclosure and in the listed claims. In an embodiment of the double triggering detection system, all three of the above conditions must be present for the double triggering detection module 224 to detect a double trigger.

The three thresholds listed above are just one example list of possible conditions that could be used to indicate double triggering. Any suitable list of conditions for determining the occurrence of double triggering may be utilized. For example, other suitable conditions/thresholds that may be utilized to determine that double triggering is implicated include a determination that the patient circuit has not become disconnected, an analysis of pressure during exhalation, a comparison of the estimated patient's neural inspiratory time to inspiratory time delivered by the ventilator, an analysis of end tidal carbon dioxide (ETCO₂), an analysis of volumetric carbon dioxide (VCO₂), a determination that the expired volume is less than 50% of the delivered volume, a determination that monitored PEEP is a negative number for one second or less during the inspiratory effort, and an analysis of a ratio of inspiratory to expiratory time (I:E ratio).

Ventilator 202 may further include a smart prompt module 226. As may be appreciated, multiple ventilatory parameters may be monitored and evaluated in order to detect an implication of double triggering. In addition, when double triggering is implicated, many clinicians may not be aware of adjustments to ventilatory parameters that may reduce or eliminate double triggering. As such, upon detection of double triggering, the smart prompt module 226 may be configured to notify the clinician that double triggering is implicated and/or to provide recommendations to the clinician for mitigating double triggering. For example, smart prompt module 226 may be configured to notify the clinician by displaying a smart prompt on display monitor 204 and/or within a window of the GUI. According to additional embodiments, the smart prompt may be communicated to and/or displayed on a remote monitoring system communicatively coupled to ventilatory system 200. Alternatively, in an automated embodiment, the smart prompt module 226 may communicate with a ventilator control system so that the recommendation may be automatically implemented to mitigate double triggering.

In order to accomplish the various aspects of the notification and/or recommendation message display, the smart prompt module 226 may communicate with various other components and/or modules. For instance, smart prompt module 226 may be in communication with data processing module 222, double triggering detection module 224, or any other suitable module or component of the ventilatory system 200. That is, smart prompt module 226 may receive an indication that double triggering has been implicated by any suitable means. In addition, smart prompt module 226 may receive information regarding one or more parameters that implicated the presence of double triggering and information regarding the patient's ventilatory settings and treatment. Further, according to some embodiments, the smart prompt module 226 may have access to a patient's diagnostic information (e.g., regarding whether the patient has ARDS, COPD, asthma, emphysema, or any other disease, disorder, or condition).

Smart prompt module 226 may further comprise additional modules for making notifications and/or recommendations to a clinician regarding the presence of double triggering. For example, according to embodiments, smart prompt module 226 may include a notification module 228 and a recommendation module 230. For instance, smart prompts may be provided according to a hierarchical structure such that a notification message and/or a recommendation message may be initially presented in summarized form and, upon clinician selection, an additional detailed notification and/or recommendation message may be displayed. According to alternative embodiments, a notification message may be initially presented and, upon clinician selection, a recommendation message may be displayed. Alternatively or additionally, the notification message may be simultaneously displayed with the recommendation message in any suitable format or configuration.

Specifically, according to embodiments, the notification message may alert the clinician as to the detection of a patient condition, a change in patient condition, or an effectiveness of ventilatory treatment. For example, the notification message may alert the clinician that double triggering has been detected. The notification message may further alert the clinician regarding the particular ventilatory parameter(s) that implicated double triggering (e.g., T_E<210 ms, etc.)

Additionally, according to embodiments, the recommendation message may provide various suggestions to the clinician for addressing a detected condition. That is, if double triggering has been detected, the recommendation message may suggest that the clinician consider changing to a spontaneous breath type, such as PA, PS, or VS etc. According to additional embodiments, the recommendation message may be based on the particular ventilatory parameter(s) that implicated double triggering. Additionally or alternatively, the recommendation message may be based on current ventilatory settings (e.g., breath type) such that suggestions are directed to a particular patient's treatment. Additionally or alternatively, the recommendation message may be based on a diagnosis and/or other patient attributes. Further still, the recommendation message may include a primary recommendation message and a secondary recommendation message.

As described above, smart prompt module 226 may also be configured with notification module 228 and recommendation module 230. The notification module 228 may be in communication with data processing module 222, double triggering detection module 224, or any other suitable module to receive an indication that double triggering has been detected. Notification module 228 may be responsible for generating a notification message via any suitable means. For example, the notification message may be provided as a tab, banner, dialog box, or other similar type of display. Further, the notification messages may be provided along a border of the graphical user interface, near an alarm display or bar, or in any other suitable location. A shape and size of the notification message may further be optimized for easy viewing with minimal interference to other ventilatory displays. The notification message may be further configured with a combination of icons and text such that the clinician may readily identify the message as a notification message.

The recommendation module 230 may be responsible for generating one or more recommendation messages via any suitable means. The one or more recommendation messages may provide suggestions and information regarding addressing a detected condition and may be accessible from the notification message. For example, the one or more recommendation messages may identify the parameters that implicated the detected condition, may provide suggestions for adjusting one or more ventilatory parameters to address the detected condition, may provide suggestions for checking ventilatory equipment or patient position, or may provide other helpful information. Specifically, the one or more recommendation messages may provide suggestions and information regarding double triggering.

According to embodiments, based on the particular parameters that implicated double triggering, the recommendation module 230 may provide suggestions for addressing double triggering. That is, if double triggering is implicated, the one or more recommendation messages may include suggestions for the following:

• • increasing T_I by changing the flow pattern, setting to decelerating ramp;
  • changing the flow pattern setting to decelerating ramp;
  • increasing set T_I;
  • decreasing set E_SENS;
  • decreasing peak flow;
  • increasing set V_T;
  • changing modes or breath types;
  • increasing set V_T while increasing peak flow rate setting to maintain T_I;
  • increasing peak flow rate setting to maintain T_I;
  • increasing set V_T and changing the flow pattern to square;
  • changing flow pattern to square; and
  • etc.

Additionally or alternatively, the one or more recommendation messages may be based on a patient's diagnosis or other clinical data. According to some embodiments, if a patient has been diagnosed with COPD, the ventilator may be configured with adjusted thresholds. In further embodiments, if a patient has been diagnosed with emphysema, the ventilator may be configured with adjusted thresholds accordingly.

According to still other embodiments, the recommendation message may include a primary message and a secondary message. That is, a primary message may provide suggestions that are specifically targeted to the detected condition based on the particular parameters that implicated the condition. Alternatively, the primary message may provide suggestions that may provide a higher likelihood of mitigating the detected condition. The secondary message may provide more general suggestions and/or information that may aid the clinician in further addressing and/or mitigating the detected condition. For example, the primary message may provide a specific suggestion tor adjusting a particular parameter to mitigate the detected condition (e.g., consider decreasing set E_SENS). Alternatively, the secondary message may provide general suggestions for addressing the detected condition.

Additionally or alternatively, the one or more recommendation messages may also be based on current ventilator settings for the patient. For example, if double triggering was implicated during a VC breath type, where the patient's current ventilator settings included a set T_I<IBW-predicted T_I, flow pattern set to square, and set V_T≧8 ml/kg, then the one or more recommendation messages may suggest increasing the time for inspiration by changing the flow pattern setting to a decelerating ramp or decreasing the peak flow rate. Further in this example, a secondary recommendation message may suggest changing the breath type to VC+, PC, or a spontaneous breath type, such as PA, PS, or VS. Table 1 below lists various example primary and secondary recommendations for volume-control ventilation based on the listed current ventilator settings.

TABLE 1
VC ventilation recommendation messages based on current ventilator settings.
Ventilator Settings	Primary Recommendation Message	Secondary Recommendation Message
Set (calculated) TI is <	Consider increasing the time	Consider changing to VC+,
IBW-predicted TI;	for inspiration by changing	PC or a spontaneous breath
Flow pattern is set to	the flow pattern setting to	type such as PA, PS, VS.
square; and	decelerating ramp,
Set VT < 8 ml/kg.	decreasing peak flow rate, or
	increasing set VT.
Set (calculated) TI is <	Consider increasing the time	Consider changing to VC+,
IBW-predicted TI;	for inspiration by decreasing	PC or a spontaneous breath
Flow pattern is set to	the peak flow rate setting.	type such as PA, PS, or VS.
decelerating ramp; and
VT ≧ 8 ml/kg.
Set (calculated) TI is <	Consider increasing the time	Consider changing to VC+,
IBW-predicted TI;	for inspiration by decreasing	PC or a spontaneous breath
Flow pattern is set to	the peak flow rate setting or	type such as PA, PS, VS.
decelerating ramp; and	increasing set VT.
VT < 8 ml/kg.
Set (calculated) TI is ≧	Consider increasing set VT	Consider changing to VC+,
IBW-predicted TI; and	while increasing the peak	PC or a spontaneous breath
Flow pattern is set to	flow rate setting to maintain	type such as PA, PS, or VS.
square.	TI.
Set (calculated) TI is ≧	Consider increasing set VT	Consider changing to VC+,
IBW-predicted TI; and	while changing the flow	PC or a spontaneous breath
Flow pattern is set to	pattern setting to square	type such as PA, PS, or VS.
decelerating ramp.	and/or increasing the peak
	flow rate setting to maintain
	TI.

In some embodiments, if double triggering is implicated during a PC or VC+ breath type, the one or more recommendation messages may suggest increasing a set T_I.

According to further embodiments, if double triggering is implicated during the PC or VC+ breath type, a secondary recommendation message may suggest changing to a spontaneous breath type, such as PA, PS, or VS breath type.

According to further embodiments, if double triggering is implicated during a PS or VS breath type, the one or more recommendation messages may suggest decreasing a set E_sens. In some embodiments, if double triggering is implicated during the PS or VS breath type, a secondary recommendation message may suggest changing to a spontaneous breath type, such as PA.

Smart prompt module 226 may also be configured such that notification and/or recommendation messages may be displayed in a partially transparent window or format. The transparency may allow for notification and/or recommendation messages to be displayed such that normal ventilator GUI and respiratory data may be visualized behind the messages. This feature may be particularly useful for displaying detailed messages. As described previously, notification and/or recommendation messages may be displayed in areas of the display screen that are either blank or that cause minimal distraction from the respiratory data and other graphical, representations provided by the GUI. However, upon selective expansion of a message, respiratory data and graphs may be at least partially obscured. As a result, translucent display may provide the detailed message such that it is partially transparent. Thus, graphical and other data may be visible behind the detailed alarm message.

Additionally, notification and/or recommendation messages may provide immediate access to the display and/or settings screens associated with the detected condition. For example, an associated parameter settings screen may be accessed from a notification and/or a recommendation message via a hyperlink such that the clinician may address the detected condition as necessary. An associated parameter display screen may also be accessed such that the clinician may view clinical data associated with the detected condition in the form of charts, graphs, or otherwise. That is, according to embodiments, the clinician may access the ventilatory data that implicated the detected condition for verification purposes. For example, when double triggering has been implicated, depending on the particular ventilatory parameters that implicated the double triggering, the clinician may be able to access ventilatory settings for addressing double triggering (e.g., a settings screen for adjusting V_T, T_I, etc.) and/or to view associated ventilatory parameters that implicated double triggering (e.g., a graphics screen displaying historical flow waveforms, volume waveforms, and/or pressure waveforms that gave rise to implications of double triggering).

According to embodiments, upon viewing the notification and/or recommendation messages, upon addressing the detected condition by adjusting one or more ventilatory settings or otherwise, or upon manual selection, the notification and/or recommendation messages may he cleared from the graphical user interface. According to some embodiments, smart prompt module 226 clears the one or more messages from the graphical user interface if the breath type is changed. In further embodiments, smart prompt module 226 clears the one or more messages from the graphical user interlace if a ventilator setting change was performed by the operator and within a predetermined amount of time (e.g. 60 seconds or 180 seconds) two patient-initiated mandatory breaths are greater than the predetermined expiratory time threshold (e.g. ≧210 ms) and/or none of the patient-initiated mandatory breaths have an expiratory time less than the predetermined expiratory time threshold (e.g. <210 ms), in further embodiments, smart prompt module 226 clears the one or more messages from the graphical user interface, if within a predetermined amount of time (e.g. 60 seconds or 180 seconds) three patient-initiated mandatory breaths are greater than the predetermined expiratory time threshold (e.g., ≧210 ms) and/or none of the patient-initiated mandatory breaths have an expiratory time less than the predetermined expiratory time threshold (e.g., <210 ms).

Double Triggering Detection during Ventilation of a Patient

FIG. 3 is a flow chart illustrating an embodiment of a method 300 for detecting an implication of double triggering.

As should be appreciated, the particular steps and methods described herein are not exclusive and, as will be understood by those skilled in the art, the particular ordering of steps as described herein is not intended to limit the method, e.g., steps may be performed in differing order, additional steps may be performed, and disclosed steps may be excluded without departing from the spirit of the present methods.

The illustrated embodiment of the method 300 depicts a method for detecting double triggering during ventilation of a patient. Method 300 begins with an initiate ventilation operation 302. Initiate ventilation operation 302 may further include various additional operations. For example, initiate ventilation operation 302 may include receiving one or more ventilatory settings associated with ventilation of a patient (e.g., at receive settings operation 304). For example, the ventilator may be configured to provide ventilation to a patient. As such, the ventilatory settings and/or input received may include a prescribed V_T, set flow (or peak flow), predicted or ideal body weight (PBW or IBW), etc. According to some embodiments, a predicted T_E may be determined based on normal respiratory and compliance values or value ranges based on the patient's PBW or IBW.

According to some embodiments, initiate ventilation operation 302 may further include receiving diagnostic-information regarding the patient (e.g., at receive diagnosis operation 306, represented with dashed lines to identify the receive diagnosis operation 306 as optional). For example, according to embodiments, the clinician may indicate that the patient has been diagnosed with ARDS, COPD, emphysema, asthma, etc. The ventilator may be further configured to associate a patient diagnosis with various conditions (e.g., increased resistance associated with COPD, increased likelihood of alveolar collapse associated with ARDS, etc.).

At deliver ventilation operation 308, the ventilator provides ventilation to a patient, as described above. That is, according to embodiments, the ventilator provides ventilation based on the set breath type. For example, during a VC breath type, the ventilator provides ventilation based on a prescribed V_T. In this example, the ventilator may deliver gases to the patient at a set flow at a set RR. When prescribed V_T has been delivered, the ventilator may initiate the expiratory phase.

While ventilation is being delivered, the ventilator may conduct various data processing operations. For example, at data processing operation 310, the ventilator may collect and/or derive various ventilatory parameter data associated with ventilation of the patient. For example, as described above, the ventilator may collect data regarding expiratory time, V_T, T_I, etc. parameters. Additionally, the ventilator may derive various ventilatory parameter data based on the collected data, e.g., IBW-predicted T_I, volume, respiratory resistance, respiratory compliance, etc. As described previously, measurements for respiratory resistance and/or compliance may be trended continuously for a patient because ventilatory data may he obtained without sedating the patient or otherwise. Additionally, the ventilator may generate various graphical representations of the collected and/or derived ventilatory parameter data, e.g., flow waveforms, pressure waveforms, pressure-volume loops, flow-volume loops, etc.

At analyze operation 312, the ventilator may evaluate collected and/or derived data to determine whether a certain patient condition exists. For example, according to embodiments, the ventilator may evaluate the various collected and derived parameter data, including expiratory time, delivered tidal volume, etc., based on one or more predetermined thresholds. According to embodiments, the ventilator may further evaluate the ventilatory parameter data in light of the patient's specific parameter settings, including set tidal volume, etc., and/or the patient's diagnostic information. In some embodiments, the evaluation of the various collected and derived parameter data includes a patient circuit disconnection operation. The patient circuit disconnection operation determines whether the patient circuit has become disconnected from the patient and/or ventilator. The analyze operation 312 determines that a patient circuit is disconnected by any suitable means. In some embodiments, the analyze operation 312 determines that the patient circuit has become disconnected by evaluating exhaled pressure and/or exhaled volume. In further embodiments, analyze operation 312 determines if the patient circuit is disconnected by determining if a disconnect alarm has been executed. If the disconnect alarm has been executed, then analyze operation 312 determines that the patient circuit is disconnected. If the disconnect alarm has not been executed, then analyze operation 312 determines that the patient circuit is connected.

According to some embodiments, at detect double triggering operation 314 the ventilator may determine whether double triggering is implicated by evaluating expiratory time, exhaled tidal volume, inspiratory time setting (T_I), patient circuit connection, etc., and compare the evaluated parameters to one or more predetermined thresholds. In order to prevent unnecessary alarms, notifications, and/or recommendations, thresholds and conditions are utilized by the detect double triggering operation 314 to determine when double triggering has occurred with sufficient frequency to warrant notification of the operator. For example, in some embodiments, a double trigger that occurs in isolation from any other double trigger will not be considered enough to warrant an occurrence of double triggering by detect double triggering operation 314.

In some embodiments, at detect double triggering operation 314 the ventilator may determine whether double triggering is implicated based on a predetermined frequency. In further embodiments, at detect double triggering operation 314 the ventilator may determine whether double triggering is implicated based on whether a double trigger occurred more than three times, for more than 30% of the patient-initiated mandatory breaths, or for more than 10% of the patient-initiated mandatory breaths within a predetermined amount of time (e.g. 60 seconds or 180 seconds) at analyze operation 312. For example, a double trigger is detected when at least one of the following three predetermined thresholds are exceeded:

• • 1. expiratory time for a patient-initiated mandatory breath is less than 240 ms;
  • 2. exhaled tidal volume associated with the expiratory period is less than 10% of the delivered tidal volume of the prior inspiratory period; and
  • 3. a disconnect alarm is not detected.

In further embodiments, threshold number 1, listed above, may be any suitable period. For example, in an alternative embodiment the expiratory time threshold is an expiratory time of less than 230 ms, 220 ms, 210 ms, 200 ms, or 190 ms depending upon the type of ventilator, patient, breath type, ventilator parameters, ventilator settings, and/or ventilator modes, etc. In some embodiment, the predetermined amount of time starts at the beginning of each patient-initiated breath. If double triggering is implicated, the detect double triggering operation 314 may proceed to issue smart prompt operation 316. If double triggering is not implicated, the detect double triggering operation 314 may return to analyze operation 312.

The three thresholds listed above are just one example list of possible conditions that could be used to indicate double triggering in the detect double triggering operation 314. Any suitable list of condition for determining the occurrence of double triggering may be utilized by the detect double triggering operation 314. As may be appreciated, the ventilator may determine whether double triggering is implicated at detect double triggering operation 314 via any suitable means. Indeed, any of the above described ventilatory parameters may be evaluated according to various thresholds for detecting double triggering. Further, the disclosure regarding specific ventilatory parameters as they may implicate double triggering is not intended to be limiting. In fact, any suitable ventilatory parameter may be monitored and evaluated for detecting double triggering within the spirit of the present disclosure. As such, if double triggering is implicated via any suitable means, the detect double triggering operation 314 may proceed to issue smart prompt operation 316. If double triggering is not implicated, the detect double triggering operation 314 may return to analyze operation 312.

At issue smart prompt operation 316, the ventilator may alert the clinician via any suitable means that double triggering has been implicated. For example, according to embodiments, the ventilator may display a smart prompt including a notification message and/or a recommendation message regarding the detection of double triggering on the GUI. According to alternative embodiments, the ventilator may communicate the smart prompt, including the notification message and/or the recommendation message, to a remote monitoring system communicatively coupled to the ventilator.

According to embodiments, the notification message may alert the clinician that double triggering has been detected and, optionally, may provide information regarding the ventilatory parameter(s) that implicated double triggering. According to additional embodiments, the recommendation message may provide one or more suggestions for mitigating double triggering. According to further embodiments, the one or more suggestions may be based on the patient's particular ventilatory settings (e.g. breath type, T_I, V_T, etc.) and/or diagnosis. According to some embodiments, the clinician may access one or more parameter setting and/or display screens from the smart prompt via a hyperlink or otherwise for addressing doable triggering. According to additional or alternative embodiments, a clinician may remotely access one or more parameter and/or display screens from the smart prompt via a hyperlink or otherwise for remotely addressing double triggering.

Smart Prompt Generation regarding Double Triggering Detection

FIG. 4 is a flow chart illustrating an embodiment of a method 400 for issuing a smart prompt upon detecting an implication of double triggering.

As should be appreciated, the particular steps and methods described herein are not exclusive and, as will be understood by those skilled in the art, the particular ordering of steps as described herein is not intended to limit the method, e.g., steps may be performed in differing order, additional steps may be performed, and disclosed steps may be excluded without departing from the spirit of the present methods.

The illustrated embodiment of the method 400 depicts a method for issuing a smart prompt upon detecting double triggering during ventilation of a patient. Method 400 begins with detect operation 402, wherein the ventilator defects that double triggering is implicated, as described above in method 300.

At identify ventilatory parameters operation 404, the ventilator may identify one or more ventilatory parameters that implicated double triggering. In order to prevent unnecessary alarms, notifications, and/or recommendations, thresholds and conditions are utilized by identify ventilatory parameters operation 404 to determine when double triggering has occurred with sufficient infrequency to warrant notification of the operator. For example, in some embodiments, a double trigger that occurs in isolation from any other double trigger will not be considered enough to warrant an occurrence of double triggering by identify ventilatory parameters operation 404.

For example, the ventilator may recognize that double triggering was implicated based on whether a double trigger occurred, more than three times for more than 30% of the patient-initiated mandatory breaths, or for more than 10% of the patient-initiated mandatory breaths within a predetermined amount of time (e.g. 60 seconds or 180 seconds). For example, a double trigger happens when at least one of three following predetermined thresholds are exceeded:

• • 1. expiratory time for a patient-initiated mandatory breath is less than 240 ms;
  • 2. exhaled tidal volume associated with the expiratory period is less than 10% of the delivered tidal volume of the prior inspiratory period; and
  • 3. a disconnect alarm is not detected.

In further embodiments, threshold number 1, listed above, may refer to any suitable expiratory period. For example, in an alternative embodiment the expiratory time threshold is an expiratory time of less than 230 ms, 220 ms, 210 ms, 200 ms, or 190 ms depending upon the type of ventilator, patient, breath type, ventilator parameters, ventilator setting, and/or ventilator modes, etc. In some embodiment, the predetermined amount of time starts at the beginning of each patient-initiated breath. The three thresholds listed above are just one example list of possible conditions that could be used to indicate double triggering in the parameters operation 404. Any suitable list of conditions for determining the occurrence of double triggering may be utilized by the parameters operation 404. As may be appreciated, the ventilator may use information regarding ventilatory parameters that implicated double triggering in determining an appropriate notification and/or recommendation message of the smart prompt.

At identify settings operation 406, the ventilator may identify one or more current ventilatory settings associated with the ventilatory treatment of the patient. For example, current ventilatory settings may have been received upon initiating ventilation for the patient and may have been determined by the clinician or otherwise (e.g., breath type, oxygenation, PBW or IBW, disease conditions, etc.). For instance, current ventilatory settings associated with ventilation for a patient may include, V_T, T_I, flow, E_SENS, flow pattern, IBW-predicted based on T_I etc. In addition, a predicted T_E may have been determined based on normal respiratory resistance and compliance values and the patient's PBW (or IBW). As may be appreciated, the ventilator may use information regarding current ventilatory settings in determining an appropriate notification and/or recommendation message of the smart prompt.

At identify patient diagnosis operation 408, the ventilator may optionally identify patient diagnosis information received from a clinician (represented with dashed lines to identity the operation as optional). For example, according to embodiments, the clinician may indicate during ventilation initiation or otherwise that the patient was diagnosed with COPD, ARDS, emphysema, asthma, etc. As may be appreciated, the ventilator may use information regarding a patient's diagnosis in determining an appropriate notification and/or recommendation message of the smart prompt.

At determine operation 410, the ventilator may determine an appropriate notification message. For example, the appropriate notification message may alert the clinician that double triggering has been implicated and, optionally, may provide information regarding the ventilatory parameter(s) that implicated double triggering. For example, the appropriate notification may alert the clinician that double triggering was implicated because a double trigger occurred in more than 10% of the patient-initiated mandatory breaths, more than 30% of the patient-initiated mandatory breaths, more than three instances of the patient-initiated mandatory breaths, more than 8 instances of the patient-initiated mandatory breaths, etc. within the predetermined amount of time. In some embodiments, the predetermined amount of time is measured from the beginning of each patient-initiated breath. For example, if double triggering was detected because a double trigger was detected in 3 or more instances of the patient-initiated mandatory breaths within the last 60 seconds, the ventilator may offer one or more notification messages that may include: “Double triggering has occurred in more than 3 instances of the breaths in one minute.” In alternative embodiments, measured parameters such as inspiratory time and volume may be utilized as the notification message.

At determine operation 412, the ventilator may determine an appropriate primary recommendation message. The appropriate primary recommendation message may provide one or more specific suggestions for mitigating double triggering. According to some embodiments, in determining the appropriate primary recommendation message, the ventilator may take into consideration the one or more monitored ventilatory parameters that implicated double triggering.

According to other embodiments, in determining an appropriate primary recommendation message the ventilator may take into consideration one or more of the patient's ventilatory settings. For example, if the breath type is volume-control (VC) and if T_I is greater than an IBW-predicted T_I, and the flow pattern is set to decelerating ramp, the ventilator may offer one or more recommendation messages that may include: “Consider increasing set V_T while changing flow pattern setting to square”; “Consider increasing peak flow rate setting to maintain T_I.” In another example, if the breath type is set to pressure-control, then the ventilator may offer one or more recommendation messages that may include: “Consider increasing the set T_I.” Any of the primary recommendations as discussed above for any breath type may be utilized by method 400.

According to further embodiments, in determining the appropriate primary recommendation message the ventilator may take into consideration the patient's diagnosis. For example, if a patient has been diagnosed with COPD or ARDS, in determining an appropriate primary recommendation message, the ventilator may consider the patient's diagnosis.

At determine operation 414, the ventilator may determine an appropriate secondary recommendation message. The secondary recommendation message may provide one or more general suggestions for mitigating double triggering. For example, the secondary recommendation message may include: “Consider changing to VC+ or PC; Consider changing to spontaneous breath type such as PA, PS, or VS; Consider changing to a spontaneous breath type such as PA.” The secondary recommendation message may provide additional recommendations for mitigating double triggering. In further embodiments, the appropriate secondary recommendation message may take into consideration the patient's current ventilatory settings. That is, during a PS or a VS breath type, the ventilator may suggest changing to a spontaneous breath type such as PA in the secondary recommendation message.

At issue smart prompt operation 416, the ventilator may alert the clinician via any suitable means that double triggering has been implicated. For example, according to embodiments, a smart prompt may include an appropriate notification message and an appropriate recommendation message regarding the presence of double triggering. Additionally or alternatively, the smart prompt may include an appropriate notification message, an appropriate primary recommendation message, and an appropriate secondary recommendation message. The smart prompt may be displayed via any suitable means, e.g., on the ventilator GUI and/or at a remote monitoring station, such that the clinician is alerted as to the potential presence of double triggering and offered additional information and/or recommendations for mitigating the double triggering, as described herein.

In some embodiments, a ventilatory system for issuing a smart prompt when double triggering is implicated during ventilation of a patient is disclosed. The ventilatory system includes: means for collecting data associated with ventilatory parameters; means for processing the collected ventilatory parameter data, wherein the means for processing the collected ventilatory parameter data includes means for deriving ventilatory parameter data from the collected ventilatory parameter data; means for analyzing the processed ventilatory parameter data, wherein the means for analyzing the processed ventilatory parameter data includes: means for receiving at least one predetermined threshold associated with the processed ventilatory parameter data; and means for detecting whether the processed ventilatory parameter data breaches the received at least one predetermined threshold at a predetermined frequency; means for determining that double triggering is implicated for a patient upon detecting that the processed ventilatory data breaches the received at least one predetermined threshold at the predetermined frequency; and means for issuing a smart prompt when the double triggering is implicated. In further embodiments, the means for the medical ventilator are illustrated in FIGS. 1 and 2 and are described in the above descriptions of FIGS. 1 and 2. However, the means described above for FIGS. 1 and 2 and illustrated in FIGS. 1 and 2 are but one example only and are not meant to be limiting.

Ventilator GUI Display of Initial Smart Prompt

FIG. 5 is an illustration of an embodiment of a graphical user interface 500 displaying a smart prompt having a notification message 512.

Graphical user interface 500 may display various monitored and/or derived data to the clinician during ventilation of a patient. In addition, graphical user interface 500 may display various messages to the clinician (e.g., alarm messages, etc.). Specifically, graphical user interlace 500 may display a smart prompt as described herein.

According to embodiments, the ventilator may monitor and evaluate various ventilatory parameters based on one or more predetermined thresholds to detect double triggering. As illustrated, a flow waveform may be generated and displayed by the ventilator on graphical user interlace 500. As further illustrated, the flow waveform may be displayed such that inspiratory flow 502 is represented in a different color (e.g., green) than explanatory flow 504 (e.g., yellow). Additionally, as illustrated, a double trigger 506 occurs when the ventilator delivers two or more breaths separated by a very short expiratory time, with at least one breath being triggered by the patient. Double triggering results when there is a mismatch between the ventilation setting for inspiratory time and the patient's neurological inspiratory time. Double triggering may also result when there is a mismatch between the flow and set inspiratory time and the patient's desired flow and neurological inspiratory time. In order to prevent unnecessary alarms, notifications, and/or recommendations, thresholds and conditions are utilized to determine when double triggering has occurred with sufficient frequency to warrant notification of the operator.

That is, double triggering may be detected if a double trigger occurred more than three times, for more than 30% of the patient-initiated mandatory breaths, or for more than 10% of the patient-initiated mandatory breaths within a predetermined amount of time (e.g. 60 seconds or 180 seconds). For example, a double trigger happens when at least one of three following predetermined thresholds are breached:

• • 1. expiratory time for a patient-initiated mandatory breath is less than 240 ms;
  • 2. exhaled tidal volume associated with the expiratory period is less than 10% of the delivered tidal volume of the prior inspiratory period; and
  • 3. a disconnect alarm is not detected.

In further embodiments, threshold number 1, listed above, may be any suitable period. For example, in an alternative embodiment the expiratory time threshold is an expiratory time of less than 230 ms, 220 ms, 210 ms, 200 ms, or 190 ms depending upon the type of ventilator, patient, breath type, ventilator parameters, ventilator setting, and/or ventilator modes, etc. In some embodiment, the predetermined amount of time starts at the beginning of each patient-initiated breath. The three thresholds listed above are just one example list of possible conditions that could be used to indicate doable triggering. Any suitable list of conditions for determining the occurrence of double triggering may be utilized.

Upon a determination that double triggering is implicated, the graphical user interlace 500 may display a smart prompt, e.g., smart prompt 510.

According to embodiments, smart prompt 510 may be displayed in any suitable location such that a clinician may be alerted regarding a detected patient condition, but while allowing other ventilatory displays and data to be visualized substantially simultaneously. As illustrated, smart prompt 510 is presented as a bar or banner across an upper region of the graphical user interlace 500. However, as previously noted, smart prompt 510 may be displayed as a tab, icon, button, banner, bar, or any other suitable shape or form. Further, smart prompt 510 may be displayed in any suitable location within the graphical user interface 500. For example, smart prompt 510 may be located along any border region of the graphical user interface 500 (e.g., top, bottom, or side borders) (not shown), across an upper region (shown), or in any other suitable location. Further, as described herein, smart prompt 510 may he partially transparent (not shown) such that ventilatory displays and data may be at feast partially visible behind smart prompt 510.

Specifically, smart prompt 510 may alert the clinician that double triggering has been defected, for example by notification message 512. As described herein, notification message 512 may alert the clinician that double triggering is implicated via any suitable means, e.g., “Double Triggering Alert” (shown), “Double Triggering Detected” (not shown), or “Double Triggering Implicated” (not shown). Smart prompt 510 may further include information regarding ventilatory parameters that implicated double triggering. For example, if double triggering was detected based on two set mechanical breaths being delivered for one patient-initiated mandatory breath three times in one minute, this information may be displayed by the notification message 512 (e.g., “Double Triggering has occurred in more than 10% of the breaths in a minute,” shown). According to the illustrated embodiment, parameter information 514 is provided along with the notification message 312 in a banner. According to alternative embodiments, in addition to the notification message 512 and the parameter information 514, one or more recommendation messages may be provided in an initial smart prompt banner (not shown). According to other embodiments, rather than providing information regarding ventilatory parameters that implicated double triggering in the initial smart prompt, this information may be provided within an expanded portion (not shown) of smart prompt 510.

According to embodiments, smart prompt 510 may be expanded to provide additional information and/or recommendations to the clinician regarding a detected patient condition. For example, an expand icon 516 may be provided within a suitable area of the smart prompt 510. According to embodiments, upon selection of the expand icon 516 via any suitable means, the clinician may optionally expand the smart prompt 510 to acquire additional information and/or recommendations for mitigating the detected patient condition. According to further embodiments, smart prompt 510 may include links (not shown) to additional settings and/or display screens of the graphical user interface 500 such that the clinician may easily and quickly mitigate and/or verify the detected condition.

As may be appreciated, the disclosed data, graphics, and smart prompt illustrated in graphical user interface 500 may be arranged in any suitable order or configuration such that information and alerts may be communicated to the clinician in an efficient and orderly manner. The disclosed data, graphics, and smart prompt are not to be understood as an exclusive array, as any number of similar suitable elements may be displayed for the clinician within the spirit of the present disclosure. Further, the disclosed data, graphics, and smart prompt are not to be understood as a necessary array, as any number of the disclosed elements may be appropriately replaced by other suitable elements without departing from the spirit of the present disclosure. The illustrated embodiment of the graphical user interface 500 is provided as an example only, including potentially useful information and alerts that may be provided to the clinician to facilitate communication of detected double triggering in an orderly and informative way, as described herein.

Ventilator GUI Display of Expanded Smart Prompt

FIG. 6 is an illustration of an embodiment of a graphical user interlace 600 displaying an expanded smart prompt 606 having a notification message and one or more recommendation messages 608.

Graphical user interface 600 may display various monitored and/or derived data to the clinician during ventilation of a patient. In addition, graphical user interface 600 may display an expanded smart prompt 606 including one or more recommendation messages 608 as described herein.

According to embodiments, as described above, an expand icon 604 may be provided within a suitable area of smart prompt 602. Upon selection of the expand icon 604, the clinician may optionally expand smart prompt 602 to acquire additional information and/or recommendations for mitigating the detected patient condition. For example, expanded smart prompt 606 may be provided upon selection of expand icon 604. As described above for smart prompt 510, expanded smart prompt 606 may be displayed as a tab, icon, button, banner, bar, or any other suitable shape or form. Further, expanded smart prompt 606 may be displayed in any suitable location within the graphical user interface 600. For example, expanded smart prompt 606 may be displayed below (shown) smart prompt 602, to a side (not shown) of smart prompt 602, or otherwise logically associated with smart prompt 602. According to other embodiments, an initial smart prompt may be hidden (not shown) upon displaying expanded smart prompt 606. Expanded small prompt 606 may also be partially transparent (not shown) such that ventilatory displays and data may be at least partially visible behind expanded smart prompt 606.

According to embodiments, expanded smart prompt 606 may comprise additional information (not shown) and/or one or more recommendation messages 608 regarding detected double triggering. For example, the one or more recommendation messages 608 may include a primary recommendation message and a secondary recommendation message. The primary recommendation message may provide one or more specific suggestions for mitigating double triggering. For example, if double triggering was implicated during volume-control ventilation and if T_I is greater than a IBW-predicted T_I and the flow pattern is set to decelerating ramp, then the ventilator may offer one or more primary recommendation messages 608 that may include: “Consider increasing set V_T while changing flow pattern setting to square; Consider changing to VC+ or PC; Consider changing to spontaneous breath type such as PA, PS, or VS; Consider increasing peak flow rate setting to maintain T_I.” The secondary recommendation message may provide one or more general suggestions for mitigating doable triggering. For example, the secondary recommendation message may include: “Consider changing to VC+ or PC; Consider changing to spontaneous breath type such as PA, PS, or VS; Consider changing to a spontaneous breath type such as PA.”

According to embodiments, expanded smart prompt 606 may also include one or more hyperlinks 610, which may provide immediate access to the display and/or settings screens associated with detected double triggering. For example, associated parameter settings screens may be accessed from expanded smart prompt 606 via hyperlinks 610 such that the clinician may address detected double triggering by adjusting one or more parameter settings as necessary. Alternatively, associated parameter display screens may be accessed such that the clinician may view clinical data associated with double triggering in the form of charts, graphs, or otherwise. That is, according to embodiments, the clinician may access the ventilatory data that implicated double triggering for verification purposes. For example, when double triggering has been implicated, depending on the particular ventilatory parameters that implicated double triggering, the clinician may be able to access associated parameter settings screens for addressing double triggering (e.g., settings screens for adjusting V_T, T_I, breath type, etc). Additionally or alternatively, the clinician may be able to access and/or view display screens associated with the ventilatory parameters that implicated double triggering (e.g., a graphics screen displaying historical flow waveforms, volume waveforms, and/or pressure waveforms that gave rise to implications of double triggering).

As may be appreciated, the disclosed smart prompt and recommendation messages 608 illustrated in graphical user interface 600 may be arranged in any suitable order or configuration such that information and alerts may be communicated to the clinician in an efficient and orderly manner. Indeed the illustrated embodiment of the graphical user interface 600 is provided as an example only, including potentially useful information and recommendations that may be provided to the clinician to facilitate communication of suggestions for mitigating detected double trigging in an orderly and informative way, as described herein.

Unless otherwise indicated, all numbers expressing measurements, dimensions, and so forth used in the specification and claims are to he understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present disclosure. Further, unless otherwise stated, the term “about” shall expressly include “exactly,” consistent with the discussions regarding ranges and numerical data. Concentrations, amounts, and other numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “about 4 percent to about 7 percent” should be interpreted to include not only the explicitly recited values of about 4 percent to about 7 percent, but also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 4.5, 5.25 and 6 and subranges such as from 4-5, from 5-7, and from 5.5-6.5, etc. This same principle applies to ranges reciting only one numerical value. Furthermore, such an interpretation should apply regardless of the breadth of the range or the characteristics being described.

It will be clear that the systems and methods described herein are well adapted to attain the ends and advantages mentioned as well as those inherent therein. Those skilled in the art will recognize that the methods and systems within this specification may be implemented in many manners and as such is not to be limited by the foregoing exemplified embodiments and examples. In other words, functional elements being performed by a single or multiple components, in various combinations of hardware and software, and individual functions can be distributed among software applications at either the client or server level. In this regard, any number of the features of the different embodiments described herein may be combined into one single embodiment and alternative embodiments having fewer than or more than all of the features herein described are possible.

While various embodiments have been described for purposes of this disclosure, various changes and modifications may be made which are well within the scope of the present disclosure. Numerous other changes may be made which will readily suggest themselves to those skilled in the art and which are encompassed in the spirit of the disclosure and as defined in the appended claims.

Claims

1. A ventilator-implemented method for detecting double triggering during ventilation of a patient, the method comprising:

collecting data associated with ventilatory parameters;

processing the collected ventilatory parameter data, wherein the step of processing the collected ventilatory parameter data comprises deriving ventilatory parameter data from the collected ventilatory parameter data;

analyzing the processed ventilatory parameter data, wherein the step of analyzing the processed ventilatory parameter data comprises: receiving at least one predetermined threshold associated with the processed ventilatory parameter data; and detecting whether the processed ventilatory parameter data breaches the received at least one predetermined threshold at a predetermined frequency;

determining that double triggering is implicated upon detecting that the processed ventilatory data breaches the received at least one predetermined threshold at the predetermined frequency; and

issuing a smart prompt when the double triggering is implicated.

2. The method of claim 1, wherein the processed ventilatory parameter data comprises exhaled tidal volume, and

wherein the step of analyzing of the exhaled tidal volume further comprises: receiving a predetermined threshold for the exhaled tidal volume, the predetermined threshold comprising: an exhaled tidal volume that is less than 10 percent of a delivered tidal volume; determining the delivered tidal volume; and determining that the exhaled tidal volume is less than 10 percent of the delivered tidal volume.

3. The method of claim 1, wherein the processed ventilatory parameter data comprises an expiratory time (TE) for a patient-initiated mandatory breath.

4. The method of claim 3, wherein the step of analyzing the expiratory time (TE) for the patient-initiated mandatory breath comprises:

receiving a predetermined threshold for the expiratory time (TE) the predetermined threshold comprising: an expiratory time (TE) threshold of less than 240 ms; determining an expiratory time (TE) for the patient-initiated mandatory breath; and determining that the expiratory time (TE) is less than 240 ms.

5. The method of claim 3, wherein the step of analyzing the expiratory time (TE) for the patient-initiated mandatory breath comprises:

receiving a predetermined threshold for the expiratory time (TE), the predetermined threshold comprising: an expiratory time (TE) threshold of less than 210 ms; determining an expiratory time (TE) for the patient-initiated mandatory breath; and determining that the expiratory time (TE) is less than 210 ms.

6. The method of claim 3, wherein the step of analyzing the expiratory time (TE) for the patient-initiated mandatory breath comprises:

receiving a predetermined threshold for the expiratory time (TE) the predetermined threshold comprising: an expiratory time (TE) threshold of less than 190 ms; determining an expiratory time (TE) for the patient-initiated mandatory breath; and determining that the expiratory time (TE) is less than 190 ms.

7. The method of claim 1, wherein the processed ventilatory parameter data comprises a disconnect alarm, and

wherein the step of analyzing of the disconnect alarm comprises: determining that the disconnect alarm has not been activated.

8. The method of claim 1, further comprising:

identifying one or more ventilatory settings associated with a ventilatory treatment of the patient;

determining an appropriate smart prompt based at least in part on evaluating the one or more ventilatory settings; and

wherein the issued smart prompt is the appropriate smart prompt.

9. The method of claim 8, wherein the one or more ventilatory settings are a ventilation breath type selected from a group of ventilation breath types of pressure controlled (PC), volume-targeted-pressure-control (VC+), pressure-support (PS), and volume-support (VS).

10-22. (canceled)