Ventilation in Cardiac Arrest Resuscitation Study

Completed

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

• Registration Number: NCT05992454
• Lead Sponsor: French Defence Health Service

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-26
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Primary Completion: 2023-11-01
• Status Verified: 2024-02
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tidal volume	up to 20 minutes (end of BLS-CPR)	Measurement of volume (mL) provided by the BLS Teams \[air + oxygen\] for each manual insufflation performed by the rescuer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Paris Fire Brigade; 🇫🇷 Paris, France