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Evaluating the Performance of Invasive Ventilation During Specialized CPR

Evaluating the Performance of Invasive Ventilation During Specialized Cardiopulmonary Arrest Resuscitation: a Multicentre Observational Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06175689
Enrollment
400
Registered
2023-12-19
Start date
2023-12-10
Completion date
2025-01-01
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Arrest, Mechanical Ventilation Complication

Keywords

CPR, Cardiopulmonary Arrest, Mechanical ventilation, Volume ventilation, Pressure ventilation

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

University Hospital, Grenoble
CollaboratorOTHER
Hôpital Necker-Enfants Malades
CollaboratorOTHER
Centre Hospitalier Annecy Genevois
CollaboratorOTHER
University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (age 18 or older) * With out-of-hospital cardiorespiratory arrest * For which specialized cardiopulmonary resuscitation is indicated and started * Supported by the SMUR of the Angers University Hospital of Angers, the Necker-Enfants malades University Hospital, the Grenoble University Hospital and the hospital of Annecy-Genevois * And for which invasive mechanical ventilation on Monnal T60 transport respirator is started

Exclusion criteria

* patients for whom it is decided not to perform invasive ventilation and * Patients opposed to participating in research * Patients with a limitation of active therapies * Patients who are not members or beneficiaries of a social security scheme

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of minute ventilation depending on capnogram analysis (CO2 patterns)12 hoursActual minute ventilation (L/min) associated with the predefined CO2 patterns, expressed in L/min/pattern

Secondary

MeasureTime frameDescription
Description of ventilation12 hours* active ventilation expressed in percentage of minute ventilation * passive ventilation expressed in percentage of minute ventilation
Description of capnogram CO2 patterns12 hoursDistribution of each predefined CO2 patterns expressed in percentage of capnograms recorded per patient.
Description of CPR quality in terms of time spent to continuous compressions12 hoursCPR 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.
Description of initial cardiac rhythm during CPR12 hoursCardiac rhythm will be expressed in percentage of the entire population
Description of return of spontaneous circulation (ROSC)12 hoursPresence of return of spontaneous circulation (ROSC) will be expressed in percentage of the entire population
Survival at hospital arrival12 hoursSurvival at hospital arrival will be expressed in percentage of the entire population
Description of CPR quality in terms of chest compressions frequency12 hoursChest 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.
Description of presence of lay-rescuers CPR12 hoursProportion of presence of lay-rescuers will be expressed in percentages of the entire population
Description of initiation of CPR by-first aid12 hoursProportion of initiation of CPR first-aid will be expressed in percentages of the entire population
Description of use of automated chest compressions devices12 hoursProportion of use of automated chest compressions devices will be expressed in percentages of the entire population
Description of use of defibrillators12 hoursProportion of use of defibrillators will be expressed in percentages of the entire population
Description of use of Extra Corporeal cardio Pulmonary Resuscitation (ECPR)12 hoursProportion of use of Extra Corporeal cardio Pulmonary Resuscitation (ECPR) will be expressed in percentages of the entire population
Observation of ventilation major events12 hoursVentilation 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
Description of cardiac arrest etiologies characteristics12 hoursProportion of cardiac arrest etiologies will be expressed in percentages of the entire population

Contacts

Primary ContactFrancois Morin, MD, MSc
francois.morin@chu-angers.fr0666431611

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026