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Completed

NCT Number: NCT05992454

Ventilation in Cardiac Arrest Resuscitation Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris Fire Brigade

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EOLIFE

Device

Measurement of ventilatory parameters during manual ventilation by professional rescuers during out-of-hospital cardiac arrest

Primary outcomes

  1. Tidal volume

    Time frame: 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 outcomes

  1. chest rise

    Time frame: up to 20 minutes (end of BLS-CPR)

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

  2. Ventilation rate

    Time frame: up to 20 minutes (end of BLS-CPR)

    Ventilation rate per min. achieved by the rescuer

  3. Insufflation time

    Time frame: up to 20 minutes (end of BLS-CPR)

    Insufflation time (seconds) per ventilation procedure

  4. Face mask leakage

    Time frame: up to 20 minutes (end of BLS-CPR)

    face mask leakage per ventilation procedure

  5. Volume received by the patient

    Time frame: up to 20 minutes (end of BLS-CPR)

    Volume received (mL) by the patient per ventilation procedure

  6. Survival to day 60 after cardiac arrest

    Time frame: up to 60 days

    Survival curve over the first 60 days

Sponsors and collaborators

Lead sponsor

French Defence Health Service

Other Gov

Collaborators

  • Fire Brigade Of Paris Emergency Medicine Dept

Registry information

Official study title

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

Acronym: VECARS

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Aug 15, 2023
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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