Ventilation in Cardiac Arrest Resuscitation Study (VECARS)

An Evaluation of Manual Ventilation Practices of Professional Firefighters During Cardiopulmonary Resuscitation.

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.

Study Overview

• Status: Completed
• Conditions: Heart Arrest, Out-Of-Hospital; Basic Cardiac Life Support; CardioPulmonary Resuscitation
• Intervention / Treatment: Device: EOLIFE

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Paris Fire Brigade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Civilian population in hyperurban areas

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
chest rise	concomitant chest rise (YES/NO) during each ventilation procedure	up to 20 minutes (end of BLS-CPR)
Ventilation rate	Ventilation rate per min. achieved by the rescuer	up to 20 minutes (end of BLS-CPR)
Insufflation time	Insufflation time (seconds) per ventilation procedure	up to 20 minutes (end of BLS-CPR)
Face mask leakage	face mask leakage per ventilation procedure	up to 20 minutes (end of BLS-CPR)
Volume received by the patient	Volume received (mL) by the patient per ventilation procedure	up to 20 minutes (end of BLS-CPR)
Survival to day 60 after cardiac arrest	Survival curve over the first 60 days	up to 60 days

Collaborators and Investigators

• Sponsor: French Defence Health Service
• Collaborators: Fire Brigade Of Paris Emergency Medicine Dept
• Investigators: Principal Investigator: Frederic Lemoine, NP, Paris Fire Brigade Emergency Dept; Study Chair: Stephane Travers, MD PhD, Paris Fire Brigade Emergency Dept

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cardiopulmonary resuscitation; heart arrest; bag-valve-mask; rescuers
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2022-A02771-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No