An observational study in Cardiopulmonary Arrest and Mechanical Ventilation Complication, sponsored by University Hospital, Angers. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by University Hospital, Angers · Observational
Describe the ventilation patterns, describe the evolution of ventilation over time and describe the safety data for two strategies of ventilation (volume or pression modes) during specialized cardiopulmonary resuscitation of pre-hospital cardiorespiratory arrest: an observational and multicentre study.
Out-of-hospital cardiac arrest is a real public health issue, whose annual incidence in Europe is 67 to 170 per 110,000 inhabitants, but whose survival remains extremely low, of the order of 4.6 to 8%. Rapid implementation of the survival chain and then specialized resuscitation is therefore essential. The recommendations of the 2020 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care and the 2021 European Rescucitation Council Guidelines recently reaffirmed the quality criteria for cardiopulmonary resuscitation (CPR) basic. Thus, during this CPR, rescuers must perform optimal chest compressions, that is, at a depth of 5 cm without exceeding 6 cm and at a frequency of 100 to 120/min with the minimum interruption time. Decompression must also be of quality.
As regards the ventilation of cardiac arrest, areas of uncertainty persist. This can be done using a bag valve mask (BAVU) or a respirator, regardless of the environment. The oxygen inspired fraction (FiO2) should be as high as possible during CPR. In the case of specialized and medicalized CPR, artificial ventilation must be implemented as soon as possible. Once the orotracheal intubation is performed, the clinician must mechanically ventilate the patient at a frequency of 10 breaths per minute without interrupting chest compressions. A ventilation strategy with reduced tidal volume (6-7 mL.kg-1 weight predicted) is preferred, associated with a low positive tele-expiratory pressure (PEEP) of 0 to 5 cmH20. Despite these clear recommendations, a heterogeneity of ventilatory practices is observed.
Regarding specialized ventilator ventilation, different ventilatory strategies are available for the clinician, however the scientific literature remains poor on this subject, especially in terms of safety and effectiveness of these strategies. Volume-assisted ventilation (VAC) is the most frequently used ventilatory strategy in the world, with the theoretical advantage of controlling the volume delivered to the patient, without being able to guarantee the pressures. Other alternative modes regulated in pressure exist but have the disadvantage of not guaranteeing volumes and minute ventilation. Each of these strategies (volume or pressure mode) is used in common practice, often with a preference for this or that ventilatory technique depending on the center and the available equipment.
The investigators therefore consider it important to accurately assess the ventilatory performance of these two strategies throughout CPR.
To do this, the investigators will conduct an observational, multicentre study. This study will aim to describe the ventilation patterns, describe the evolution of ventilation over time and finally to describe the safety data, for these two strategies during specialized cardiopulmonary resuscitation of pre-hospital cardiorespiratory arrest.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's planned enrollment of 400 is above the median of 200 across 383 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population studied is that of out-of-hospital cardiorespiratory arrests managed by the emergency medicine prehospital medical teams (SMUR) of the four inclusion centers and meeting the inclusion criteria.
Exclusion Criteria:
Evaluation of minute ventilation depending on capnogram analysis (CO2 patterns)
Actual minute ventilation (L/min) associated with the predefined CO2 patterns, expressed in L/min/pattern
Time frame: 12 hours
Description of ventilation
* active ventilation expressed in percentage of minute ventilation * passive ventilation expressed in percentage of minute ventilation
Time frame: 12 hours
Description of capnogram CO2 patterns
Distribution of each predefined CO2 patterns expressed in percentage of capnograms recorded per patient.
Time frame: 12 hours
Description of CPR quality in terms of chest compressions frequency
Chest compressions frequency analysis will be expressed in time during which chest compression frequency (fCT) is within the predefined ranges (100 to 120 compressions/min) expressed in percentage.
Time frame: 12 hours
Description of CPR quality in terms of time spent to continuous compressions
CPR quality criteria analysis will be based in this analysis on CPR fraction (%CT), expressed in percentage, that expresses the percentage of time spent to continuous chest compressions over the total time of cardiopulmonary resuscitation.
Time frame: 12 hours
Description of initial cardiac rhythm during CPR
Cardiac rhythm will be expressed in percentage of the entire population
Time frame: 12 hours
Description of return of spontaneous circulation (ROSC)
Presence of return of spontaneous circulation (ROSC) will be expressed in percentage of the entire population
Time frame: 12 hours
Survival at hospital arrival
Survival at hospital arrival will be expressed in percentage of the entire population
Time frame: 12 hours
Description of cardiac arrest etiologies characteristics
Proportion of cardiac arrest etiologies will be expressed in percentages of the entire population
Time frame: 12 hours
Description of presence of lay-rescuers CPR
Proportion of presence of lay-rescuers will be expressed in percentages of the entire population
Time frame: 12 hours
Description of initiation of CPR by-first aid
Proportion of initiation of CPR first-aid will be expressed in percentages of the entire population
Time frame: 12 hours
Description of use of automated chest compressions devices
Proportion of use of automated chest compressions devices will be expressed in percentages of the entire population
Time frame: 12 hours
Description of use of defibrillators
Proportion of use of defibrillators will be expressed in percentages of the entire population
Time frame: 12 hours
Description of use of Extra Corporeal cardio Pulmonary Resuscitation (ECPR)
Proportion of use of Extra Corporeal cardio Pulmonary Resuscitation (ECPR) will be expressed in percentages of the entire population
Time frame: 12 hours
Observation of ventilation major events
Ventilation major events will be defined in percentage of the entire population: * Occurence of extubation expressed in percentage * Triggering of high pressure alarm expressed in percentage * Triggering of low volume (expired volume) alarm expressed in percentage * Occurence of hemoptysis in intubation sonde expressed in percentage * Occurence of pulmonary edema expressed in percentage
Time frame: 12 hours
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University Hospital, Angers