This application claims the benefit of priority under 35 U.S.C. § 119 (a) and (b) to French Patent Application No. 1850224, filed Jan. 11, 2018, the entire contents of which are incorporated herein by reference.
The invention relates to a respiratory assistance apparatus, that is to say a medical ventilator, for delivering a respiratory gas to a patient receiving cardiopulmonary resuscitation (CPR), that is to say a patient in cardiac arrest on whom cardiac massage is performed with alternating compression and relaxation of the chest, with display of the maximum CO2 content value measured during a given time period.
Medical apparatuses for mechanical ventilation, also called respiratory assistance apparatuses or medical ventilators, are currently used to deliver respiratory gas, for example oxygen-enriched air or non-oxygen-enriched air, to certain patients suffering from respiratory problems.
The delivery of the respiratory gas to the patient is currently effected by means of a motorized and controlled micro-blower, as is described in particular by EP-A-3093498, EP-A-2947328, EP-A-2986856, EP-A-2954213 or EP-A-2102504.
It is known to monitor the gaseous compounds present in the gas administered to the patients, particularly in the gases exhaled by the patients, which gases contain CO2 resulting from the pulmonary gas exchanges, that is to say CO2 produced by the patient's metabolism, conveyed to the lungs by the blood stream, then discharged during exhalation by the patient. Thus, etCO2, standing for End Tidal CO2 or CO2 at the end of exhalation, corresponds to the measurement of the CO2 fraction exhaled in the gases collected during the exhalation of an individual, whether the inhalation is natural or assisted, that is to say obtained by mechanical ventilation.
During mechanical ventilation, different techniques permit spectrophotometric analysis of the CO2 fraction of the exhaled gases. To do this, the gas present in the exhalation circuit may be:
During cardiopulmonary resuscitation (CPR) performed on a person in cardiopulmonary arrest, with use of cardiac massage, the alveolar CO2, which depends not only on the ratios between ventilation and pulmonary perfusion but also on the quantity of CO2 generated by the cell metabolism, is a very useful parameter for allowing the first responder, for example a physician, to judge the efficacy of the CPR.
In theory, the more effective the CPR, the greater the cardiac output generated by the chest compressions, and the larger the quantity of CO2 returned to the lungs.
Monitoring of the etCO2, which indirectly reflects the alveolar CO2, is increasingly used to monitor the CPR non-invasively, that is to say to provide information to the first responder while performing the cardiac massage, i.e. alternating chest compressions (CC) and relaxations.
However, during cardiopulmonary resuscitation (CPR) on a patient in cardiorespiratory arrest, the capnogram is very different for several reasons, notably:
It will thus be appreciated that etCO2 as measured currently, that is to say during each chest compression (CC), does not permit a reliable approximation of the alveolar CO2, although this alveolar CO2 is important because it may reflect the quality of the CPR and a possible resumption of spontaneous cardiac activity (RSCA).
The recurring problem that results from this is that a measurement of the CO2 that does not take account of all or some of these factors, in particular the impact of the ventilation performed on the patient in cardiac arrest and the variability of the CO2 signal between two machine cycles, makes the use of this CO2 measurement somewhat unreliable or even unusable.
The current solutions involving the monitoring of etCO2 are adapted to the CO2 variations produced by breathing, whether mechanical or spontaneous. The frequencies involved are of the order of 10 to 40 c/min. The algorithms and mechanisms used are adapted to these frequencies and to small variations of the CO2 between two respirations of the patient.
In this regard, mention made be made of the documents WO-A-2014/072981, US-A-2016/133160 and US-A-2012/016279, which propose methods for monitoring the CO2 content in the gases exhaled by a patient receiving CPR, in which methods the ventilators indicate that the first responder must stop the cardiac massage when the etCO2 content is greater than 30 mmHg, for example.
Now, during cardiopulmonary resuscitation, the frequencies of the chest compressions (CC) are close to 100 c/min, the volumes of gas that are mobilized are small, and the gas flow rates are considerable and irregular. Moreover, the problem of the dead space mentioned above adds to these difficulties since, on account of the chest compressions, a same fraction of gas may be analysed several times by the CO2 sensor, if there is no rinsing or purging of the dead space.
Under these conditions, the etCO2 value displayed by the current ventilators is refreshed at an inadequate frequency, since the ventilators attempt to follow the evolution of the CO2 at the massage frequency, i.e. 100 c/min. In other words, the etCO2 values displayed by the current ventilators are not representative of a CO2 concentration linked to the patient's metabolism, since the origin of the gas analysed is not guaranteed. In other words, the values measured are often erroneous since they do not reflect, or they reflect very poorly, the concentration of alveolar CO2.
The problem addressed is therefore to make available an improved respiratory assistance apparatus, that is to say a medical ventilator, with which it is possible, during CPR using the respiratory assistance apparatus, to display a reliable CO2 value, that is to say a value that best reflects the alveolar CO2, with the objective of better assisting the first responder during the CPR by providing him with pertinent information that facilitates monitoring of the CPR, such as the detection of a resumption of spontaneous cardiac activity (RSCA), for example.
The solution of the invention is therefore a respiratory assistance apparatus, that is to say a medical ventilator, for delivering a respiratory gas, such as oxygen, to a patient during cardiopulmonary resuscitation (CPR), comprising:
Depending on the case, the respiratory assistance apparatus of the invention may comprise one or more of the following technical features:
The invention also relates to a method for monitoring cardiopulmonary resuscitation (CPR) performed on a patient in cardiac arrest, in which method:
The invention will now be better understood from the following detailed description given as a non-limiting example and with reference to the appended figures, in which:
This apparatus or ventilator comprises a source 1 of respiratory gas, such as a motorized micro-blower, which is in fluidic communication with a gas conduit 2 for delivering a respiratory gas to said patient P during cardiopulmonary resuscitation, typically pressurized air.
The source 1 of respiratory gas is governed, that is to say controlled, by signal-processing and control means 5, in particular an electronic board with microprocessor 6 or similar. The signal-processing and control means 5 control the source 1 of respiratory gas in such a way that it delivers the gas in accordance with one or more predefined ventilation modes.
Preferably, the signal-processing and control means 5 make it possible to control the source 1 of respiratory gas so as to deliver the gas in accordance with a “normal” ventilatory mode, corresponding to ventilation of a patient who is not in cardiac arrest, and a “CPR” ventilatory mode, corresponding to ventilation of a patient who is in cardiac arrest and on whom a first responder initiates or performs CPR.
For example, in accordance with a ventilation mode intended for CPR, the source 1 of respiratory gas is controlled so as to deliver the respiratory gas, typically air, in a ventilatory cycle comprising several pressure levels or of the BiPAP type, as illustrated in
The gas is delivered alternately between these two pressure levels (LP, HP), as is illustrated in
The micro-blower 1 of the ventilator generates two pressure levels, namely a high-pressure level (i.e. HP) and a low-pressure level (i.e. LP). The cardiac massage alternating between phases of chest compression (CC) and relaxation (Re) generates pressure peaks, which are superposed on the pressure cycles of the ventilator. This results, at the patient interface, in a pressure curve as illustrated in
As will be seen from
The gas delivered by the micro-blower 1 is conveyed through the gas conduit 2 which forms all or part of the inhalation branch 2a of the patient circuit 2a, 2b. The respiratory gas, generally air, is delivered to the patient via a gas distribution interface 3, for example here an endotracheal intubation tube, more simply called a tracheal tube. However, other interfaces may be used, in particular a face mask or a laryngeal mask.
The gas conduit 2 is in fluidic communication with the gas distribution interface 3, such as a tracheal tube, in such a way as to supply the latter with the gas originating from the source 1 of respiratory gas, in this case a micro-blower. The gas conduit 2 will in fact be attached to the tracheal tube 3 by way of an intermediate attachment piece 8, here a Y-shaped piece. This Y-shaped intermediate attachment piece 8 comprises internal passages for gas.
The intermediate attachment piece 8, that is to say the Y-shaped piece, is likewise attached to the exhalation branch 2b of the patient circuit 2a, 2b so as to be able to collect and convey the gases rich in CO2 that are exhaled by the patient P and to discharge them to the atmosphere (at 9).
Also provided according to the invention are means 4 for measuring the CO2 content, called a CO2 sensor or capnometer, which means are designed to perform measurements of the concentration of CO2 in the gas exhaled by the patient P and to deliver CO2 content measurement signals to the signal-processing and control means 5, where these measurement signals can be processed, in particular by one or more calculation algorithms or similar.
In the embodiment in
According to another embodiment (not shown), the CO2 sensor can be arranged in the “sidestream” configuration. In this case, the CO2 sensor 4 is situated in the framework of the respiratory assistance apparatus and is connected, via a gas sampling line, such as tubing or the like, to a gas sampling site situated upstream from and in immediate proximity to the respiratory interface 3, for example on the junction piece 18. This gas sampling line communicates fluidically with the lumen of the junction piece 18 in such a way as to be able to collect a sample of the gas from there and convey it then to the CO2 sensor situated in the framework of the apparatus.
In all cases, the junction piece 18 comprises an internal passage for gas, allowing the gas to pass through it.
Preferably, the CO2 sensor performs continuous measurements of the concentration of CO2 in the gas flowing through the junction piece 18, which gas is enriched in CO2 during its passage through the lungs of the patient P, where gaseous exchanges take place.
The CO2 content measurement signals are then transmitted by the CO2 sensor to the signal-processing and control means 5 by an electrical connection or similar, in particular by wire or similar.
The monitoring of the CO2 content, in particular of the etCO2 which indirectly reflects the alveolar CO2 content, is in fact of great importance during CPR, especially for detecting a resumption of spontaneous cardiac activity (RSCA). This is because a resumption of spontaneous cardiac activity (RSCA), hence a significant increase of the cardiac output, brings about a rapid increase in the quantity of CO2 carried by the blood to the lungs and transferred through the alveolar-capillary membrane, this CO2 then being found again in the gas flow exhaled by the patient.
The signal-processing and control means 5 (in particular the microprocessor 6) are configured:
a) to process the CO2 content measurement signals corresponding to measurements performed by the CO2 content measurement means 4, typically the capnometer or CO2 sensor, during the given time period (dt), for example several seconds, in order to extract therefrom a plurality of CO2 content values.
b) to select the maximum CO2 content value (Vmax) from the plurality of CO2 content values measured during said given time period (dt), and
c) to transmit this maximum CO2 content value (Vmax) to a graphical user interface 7 or GUI.
A source 10 of electric current, such as a rechargeable battery or similar, directly or indirectly supplies electric current to the signal-processing and control means 5, the micro-blower 1, the GUI 7 or any other element of the apparatus, in particular a storage memory 11. The source 10 of electric current is preferably arranged in the framework of the ventilator.
Generally, the medical ventilator of the invention permits a continuous measurement of the concentration of CO2 produced by the patient P, the measurement being performed by the capnometer 4 which is arranged on the pathway of the gas, close to the mouth of the patient P, preferably here between the Y-shaped piece 8 and the tracheal tube 3 of
If so desired, the ventilator additionally permits parallel performance of a continuous measurement of the exhaled and inhaled gas flow rates, with the aid of one or more flow rate sensors (not shown).
According to the invention, the GUI for its part is configured to display the maximum CO2 content value supplied by the signal-processing and control means 5, which value is selected from several CO2 concentration values measured for a given duration corresponding to several successive chest compressions and relaxations performed by a first responder carrying out cardiac massage (i.e. CPR) on the patient P in cardiac arrest.
The reason is that the CO2 concentration value which best reflects the alveolar CO2 content, and which hence gives a good indication of the state of the blood flow in the patient P during the CPR, is the highest CO2 value, also called the maximum value (Vmax) or peak value, as illustrated in
Hence, in the context of the present invention, the ventilator thus stores (at 11) all the peak values of CO2 during each time period dt, typically between 3 and 7 seconds, and determines the maximum CO2 content value (Vmax) from the plurality of peaks (EtCO2—1, EtCO2—2, EtCO2—3, . . . , EtCO2—x) measured over a given time period, as is illustrated in
During CPR, the CO2 content in the gas produced by the patient, and passing the measurement tap of the capnometer 4, varies depending on the presence or absence of chest compressions (CC).
Thus, after insufflation of air by the micro-blower 1 of the ventilator and as long as chest compression has not commenced, no CO2 is detected in the gas flows passing through the conduit 2 as far as the respiratory interface 3, which then distributes this air to the lungs of the patient P.
After several chest compressions (CC) performed by a first responder, CO2 is detected at the Y-shaped piece 8 by the capnometer 4 since the alternations of chest compressions (CT) and relaxations (Re) generate movements of air entering and leaving the lungs of the patient P by “imitating” the exhalation phases of the patient P. Exhaled air rich in CO2 is then found again at the Y-shaped piece 8 and the capnometer 4 (cf
The maximum CO2 value (Vmax) is the one that best represents the alveolar CO2. In fact, the CO2 present at the Y-shaped piece 8 and the capnometer 4 is “washed out” little by little on account of the successive and repeated chest compressions and tends to decrease after reaching this maximum value, since the chest compressions thus cause the discharge to the atmosphere (at 9) of the gases rich in CO2, via the exhalation branch 2b of the patient circuit. The successive chest compressions (CC) thus generate different levels of CO2, the most representative one being the peak value or maximum value (Vmax), as is illustrated in
In the context of the present invention, the ventilator thus stores (at 11) all the maximum CO2 content values (Vmax) between two ventilatory cycles, that is to say during the successive durations dt, determines the maximum CO2 content value (Vmax) from the plurality of maximum values measured, and displays this maximum value (Vmax) on the screen of the GUI 7.
This maximum value (Vmax), during a given time interval dt, can be displayed as a single numerical value. It is also possible to display several maximum values (Vmax) measured successively over several successive time intervals (dt). Furthermore, if it is deemed useful or desirable, it is also possible to display the value in the form of a graphical representation showing several maximum values (Vmax) measured successively over several successive time intervals (dt) over the course of time, for example over the last 2 to 5 minutes, for example a graphical representation such as a curve, bar graph or similar.
The data calculated from these CO2 measurements allow the first responder to better “control” the CPR, by virtue of an indicator which reflects the state of the circulation and metabolism of the patient since, at a constant ventilation level, the more effective the CPR, the greater the quantity of CO2 produced and transferred through the alveolar-capillary membrane, hence the greater the quantity of CO2 that can be detected at the capnometer 4.
Hence, in the case of a resumption of spontaneous cardiac activity (RSCA), the circulation recovers abruptly and therefore the quantity of alveolar CO2 increases in parallel, which induces a substantial increase in the quantity of CO2 detected by the capnometer 4 by a factor often greater than 2, as is illustrated in
To put it another way, in the context of the invention, the fact that the GUI 7 displays the maximum etCO2 value, during a given time period (dt), allows the first responder to better detect the occurrence of an RSCA since this maximum CO2 value (Vmax) closely reflects the alveolar CO2.
It has in fact been found, in tests carried out in the context of the present invention, that continuously displaying all the CO2 measurements would not be effective, since the cardiac massage itself, even when carried out uniformly (pressure force, frequency, etc.), inevitably causes considerable variations in CO2 content at the capnometer from one chest compression to another. This is explained by the dynamic behaviour or opening/closing of the small airways and by the effect of lavage of the dead space during the successive chest compressions between two machine cycles. Therefore, displaying all the CO2 measurements could cause the first responder to make an error or could “drown” him under too much information, and he could then sometimes believe there was a resumption of spontaneous cardiac activity even when it was only an artefact, or, conversely, the first responder could fail to notice a resumption of spontaneous cardiac activity (RSCA) in the patient and could continue the massage when the patient is in the RSCA phase. In all cases, the use of a single instantaneous value for prognostic reasons or for choice of therapeutic strategy is made risky by the oscillating nature of the instantaneous etCO2 value, i.e. at each chest compression (CC).
In the context of the invention, it has been shown in practical tests that these problems could be completely overcome by displaying only the highest CO2 content value (Vmax) during a given time period (dt), typically of a few seconds.
In addition, it has been found that the CO2 content measured at each chest compression can vary enormously from one chest compression to another. This is due not only to the anatomical and instrumental dead space but also to the degree of opening of the patient's airways. Taking these factors into account, the maximum CO2 content value (Vmax) appears therefore to be a better reflection of the alveolar CO2 and is thus a good indicator of RSCA (if it increases abruptly) or of a new cardiac arrest (if its decreases abruptly), which informs the first responder immediately and in a more relevant way.
Thus, when the first responder notes a strong increase in the displayed CO2 value, he can conclude from this that the patient is in the RSCA phase, as is illustrated in
Advantageously, the ventilator of the invention can also include alarm means designed and programmed to warn the first responder or the like when the measured maximum CO2 value exceeds or, conversely, drops below a given value that is predefined or calculated continuously.
In particular, an acoustic and/or visual alarm is provided which triggers when the maximum CO2 content measured, at a time t, is greater than a threshold value, for example: [VmaxCO2]>1.5×[MeanCO2] where:
Similarly, the alarm can trigger in the event of the CO2 concentration dropping abruptly below a given minimum value, which could be the sign of a new cardiac arrest of the patient, of hyperventilation, or of obstruction of the gas circuit between the patient and the machine, for example a flexible conduit that is bent or crushed and no longer allows the gas to pass through.
Generally, the invention relates to a medical ventilator suitable for use during cardiopulmonary resuscitation (CPR), comprising a source 1 of respiratory gas, such as a micro-blower, means 4 for measuring the CO2 content, such as a capnometer, signal-processing and control means 5 receiving and processing the CO2 content measurement signals originating from the CO2 content measurement means 4, and a GUI 7 configured to display at least one maximum CO2 content value (Vmax) measured during a given time period (dt), said maximum CO2 content value (Vmax) being selected from a plurality of CO2 content values measured during said given time period (dt).
The respiratory assistance apparatus or medical ventilator according to the present invention is particularly suitable for use during cardiopulmonary resuscitation (CPR) on a person (i.e. a patient) in cardiopulmonary arrest, in the context of which a respiratory gas such as pressurized air is supplied, in accordance with a ventilatory cycle with several pressure levels, to said person undergoing the cardiac massage with alternating chest compressions and relaxations. To facilitate its transport by the first aid responders, for example by a physician, a nurse, a fire fighter or similar, the ventilator of the invention is preferably arranged in a bag for carrying it.
It will be understood that many additional changes in the details, materials, steps and arrangement of parts, which have been herein described in order to explain the nature of the invention, may be made by those skilled in the art within the principle and scope of the invention as expressed in the appended claims. Thus, the present invention is not intended to be limited to the specific embodiments in the examples given above.
Number | Date | Country | Kind |
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1850224 | Jan 2018 | FR | national |