Evaluating the Performance of Invasive Ventilation During Specialized CPR

December 14, 2023 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of minute ventilation depending on capnogram analysis (CO2 patterns)
Time Frame: 12 hours
Actual minute ventilation (L/min) associated with the predefined CO2 patterns, expressed in L/min/pattern
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of ventilation
Time Frame: 12 hours
  • active ventilation expressed in percentage of minute ventilation
  • passive ventilation expressed in percentage of minute ventilation
12 hours
Description of capnogram CO2 patterns
Time Frame: 12 hours
Distribution of each predefined CO2 patterns expressed in percentage of capnograms recorded per patient.
12 hours
Description of CPR quality in terms of chest compressions frequency
Time Frame: 12 hours
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.
12 hours
Description of CPR quality in terms of time spent to continuous compressions
Time Frame: 12 hours
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.
12 hours
Description of initial cardiac rhythm during CPR
Time Frame: 12 hours
Cardiac rhythm will be expressed in percentage of the entire population
12 hours
Description of return of spontaneous circulation (ROSC)
Time Frame: 12 hours
Presence of return of spontaneous circulation (ROSC) will be expressed in percentage of the entire population
12 hours
Survival at hospital arrival
Time Frame: 12 hours
Survival at hospital arrival will be expressed in percentage of the entire population
12 hours
Description of cardiac arrest etiologies characteristics
Time Frame: 12 hours
Proportion of cardiac arrest etiologies will be expressed in percentages of the entire population
12 hours
Description of presence of lay-rescuers CPR
Time Frame: 12 hours
Proportion of presence of lay-rescuers will be expressed in percentages of the entire population
12 hours
Description of initiation of CPR by-first aid
Time Frame: 12 hours
Proportion of initiation of CPR first-aid will be expressed in percentages of the entire population
12 hours
Description of use of automated chest compressions devices
Time Frame: 12 hours
Proportion of use of automated chest compressions devices will be expressed in percentages of the entire population
12 hours
Description of use of defibrillators
Time Frame: 12 hours
Proportion of use of defibrillators will be expressed in percentages of the entire population
12 hours
Description of use of Extra Corporeal cardio Pulmonary Resuscitation (ECPR)
Time Frame: 12 hours
Proportion of use of Extra Corporeal cardio Pulmonary Resuscitation (ECPR) will be expressed in percentages of the entire population
12 hours
Observation of ventilation major events
Time Frame: 12 hours

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
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

University Hospital, Grenoble
Centre Hospitalier Annecy Genevois
Hôpital Necker-Enfants Malades

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Estimated)

December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR CPV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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