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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05992454
Other study ID # 2022-A02771-42
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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