VECARS: Ventilation in Cardiac Arrest Resuscitation Study

• Sponsor: French Defence Health Service (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05992454
• Collaborator: Fire Brigade Of Paris Emergency Medicine Dept (Other)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 6.2
• Patients Per Site Per Month: 19.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Arrest, Out-Of-Hospital; CardioPulmonary Resuscitation; Basic Cardiac Life Support	Device: EOLIFE

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Evaluation of Manual Ventilation Practices of Professional Firefighters During Cardiopulmonary Resuscitation.
• Actual Study Start Date: May 26, 2023
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. Tidal volume [up to 20 minutes (end of BLS-CPR)]

   Measurement of lung volume (mL) received [air + oxygen] for each manual insufflation performed by the rescuer

Secondary Outcome Measures

1. chest rise [up to 20 minutes (end of BLS-CPR)]

   concomitant chest rise (YES/NO) during each ventilation procedure

2. Ventilation rate [up to 20 minutes (end of BLS-CPR)]

   Ventilation rate per min. achieved by the rescuer

3. Insufflation time [up to 20 minutes (end of BLS-CPR)]

   Insufflation time (seconds) per ventilation procedure

4. Face mask leakage [up to 20 minutes (end of BLS-CPR)]

   face mask leakage per ventilation procedure

5. Volume delivered by the rescuer [up to 20 minutes (end of BLS-CPR)]

   Volume delivered (mL) by the rescuer per ventilation procedure

6. Survival to day 30 after cardiac arrest [up to 30 days]

   Survival curve over the first 30 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paris Fire Brigade	Paris		France

Sponsors and Collaborators

• French Defence Health Service
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel Jost, Physician heading the scientific section, Fire Brigade Of Paris Emergency Medicine Dept
• ClinicalTrials.gov Identifier: NCT05992454
• Other Study ID Numbers: 2022-A02771-42
• First Posted: Aug 15, 2023
• Last Update Posted: Aug 15, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daniel Jost, Physician heading the scientific section, Fire Brigade Of Paris Emergency Medicine Dept: heart arrest; cardiopulmonary resuscitation; bag-valve-mask; rescuers
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

No Results Posted as of Aug 15, 2023