Ventilation in Cardiac Arrest Resuscitation Study

NCT05992454 | Completed

• 1 other identifier: 2022-A02771-42
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Out-of-hospital cardiac arrest (OHCA) is a major public health problem, with around 40,000 victims each year in France. Their survival rate remains dramatically low, at less than 10%. In the event of pre-hospital cardiac arrest, rescuers perform resuscitation techniques using equipment for which they have been trained. They perform cardiopulmonary resuscitation (CPR) by alternating 30 chest compressions with 2 insufflations (30/2) with a manual insufflator bag. In basic life supports, insufflations should result in chest rise, but guidelines do not specify a precise volume. Recently, medical devices have been developed that enable precise measurement of ventilatory volumes. In simulation, these devices show hyperventilation in volume and frequency in mannequins. But no clinical study has analyzed insufflator bag ventilation maneuvers in real-life situations on pre-hospital cardiac arrest patients. The aim of this study is to analyze ventilation parameters in current practice in relation to standards, and the factors influencing the quality of ventilation maneuvers.

Conditions

Heart Arrest, Out-Of-Hospital; CardioPulmonary Resuscitation; Basic Cardiac Life Support

Keywords

heart arrest; cardiopulmonary resuscitation; bag-valve-mask; rescuers

Outcome Measures

Primary Outcomes (1)

• Tidal volume

  Measurement of volume (mL) provided by the BLS Teams \[air + oxygen\] for each manual insufflation performed by the rescuer

  up to 20 minutes (end of BLS-CPR)

Secondary Outcomes (6)

• chest rise

  up to 20 minutes (end of BLS-CPR)

• Ventilation rate

  up to 20 minutes (end of BLS-CPR)

• Insufflation time

  up to 20 minutes (end of BLS-CPR)

• Face mask leakage

  up to 20 minutes (end of BLS-CPR)

• Volume received by the patient

  up to 20 minutes (end of BLS-CPR)

Interventions

EOLIFE DEVICE

Measurement of ventilatory parameters during manual ventilation by professional rescuers during out-of-hospital cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Civilian population in hyperurban areas

You may qualify if:

• Out of hospital cardiac arrest with CPR performed by the Firefighters
• Age 18 and over
• BLS team on site before arrival of physician staffed ALS means
• CPR ventilation initially provided with Bag-valve- mask
• Measuring device records ventilatory parameters

You may not qualify if:

• trauma related OHCA
• airway obstruction during CPR
• OHCA on hanging
• tracheostomized patient
• obstacle to using the Bag-valve-mask
• CPR time less than 2 minutes

Sponsors & Collaborators

• French Defence Health Service: lead
• Fire Brigade Of Paris Emergency Medicine Dept: collaborator

Study Sites (1)

Paris Fire Brigade

Paris, France

Location

Related Publications (1)

• Lemoine F, Jost D, Lemoine S, Petermann A, Salome M, Tassart B, Liscia J, Briche F, Bon O, Derkenne C, Frattini B, Travers S; Paris Fire Brigade Cardiac Arrest Task Force (collaborators). Manual bag-valve-mask ventilation during out-of-hospital cardiopulmonary resuscitation: a prospective observational study. Resuscitation. 2025 Dec;217:110895. doi: 10.1016/j.resuscitation.2025.110895. Epub 2025 Nov 12.

  PMID: 41237844 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Frederic Lemoine, NP

  Paris Fire Brigade Emergency Dept

  PRINCIPAL INVESTIGATOR

• Stephane Travers, MD PhD

  Paris Fire Brigade Emergency Dept

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician heading the scientific section

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 15, 2023
• Study Start: May 26, 2023
• Primary Completion: November 1, 2023
• Study Completion: February 1, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

FR (1)