Ventilation in Cardiac Arrest Resuscitation Study

CardioPulmonary Resuscitation Clinical Trial

— VECARS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05992454
• Other study ID #: 2022-A02771-42
• Status: Completed
• Start date: May 26, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: French Defence Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• EOLIFE
Measurement of ventilatory parameters during manual ventilation by professional rescuers during out-of-hospital cardiac arrest

Locations

Country	Name	City	State
France	Paris Fire Brigade	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French Defence Health Service	Fire Brigade Of Paris Emergency Medicine Dept

Country where clinical trial is conducted

France, 

Outcome

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