Clinical trial NCT05992454: Ventilation in Cardiac Arrest Resuscitation Study
Official title: An Evaluation of Manual Ventilation Practices of Professional Firefighters During Cardiopulmonary Resuscitation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest, Out-Of-Hospital
CardioPulmonary Resuscitation
Basic Cardiac Life Support
Keywords: heart arrest
cardiopulmonary resuscitation
bag-valve-mask
rescuers
Lead sponsor: French Defence Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Fire Brigade Of Paris Emergency Medicine Dept
First posted: 2023-08-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Civilian population in hyperurban areas

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tidal volume
timeFrame: up to 20 minutes (end of BLS-CPR)
Secondary outcomes:
measure: chest rise
timeFrame: up to 20 minutes (end of BLS-CPR)
measure: Ventilation rate
timeFrame: up to 20 minutes (end of BLS-CPR)
measure: Insufflation time
timeFrame: up to 20 minutes (end of BLS-CPR)
measure: Face mask leakage
timeFrame: up to 20 minutes (end of BLS-CPR)
measure: Volume received by the patient
timeFrame: up to 20 minutes (end of BLS-CPR)
measure: Survival to day 60 after cardiac arrest
timeFrame: up to 60 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris Fire Brigade
Study officials:
affiliation: Paris Fire Brigade Emergency Dept
name: Frederic Lemoine, NP
role: PRINCIPAL_INVESTIGATOR
affiliation: Paris Fire Brigade Emergency Dept
name: Stephane Travers, MD PhD
role: STUDY_CHAIR
References: