Heart Arrest, Out-Of-HospitalVECARSNCT05992454
Ventilation in Cardiac Arrest Resuscitation Study
An observational study of Heart Arrest, Out-Of-Hospital and CardioPulmonary Resuscitation, run by French Defence Health Service at 1 site in France.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest, Out-Of-Hospital, CardioPulmonary Resuscitation, Basic Cardiac Life Support
- What is being tested?
- EOLIFE
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Civilian population in hyperurban areas
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Evaluation of Manual Ventilation Practices of Professional Firefighters During Cardiopulmonary Resuscitation.
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.
Read more
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.
- Being tested
- EOLIFE
- Keywords
- heart arrest, cardiopulmonary resuscitation, bag-valve-mask, rescuers
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOLIFEDevice
Measurement of ventilatory parameters during manual ventilation by professional rescuers during out-of-hospital cardiac arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Measurement of volume (mL) provided by the BLS Teams [air + oxygen] for each manual insufflation performed by the rescuer
Measured: up to 20 minutes (end of BLS-CPR)
Secondary outcomes (6)
chest rise
concomitant chest rise (YES/NO) during each ventilation procedure
Measured: up to 20 minutes (end of BLS-CPR)
Ventilation rate
Ventilation rate per min. achieved by the rescuer
Measured: up to 20 minutes (end of BLS-CPR)
Insufflation time
Insufflation time (seconds) per ventilation procedure
Measured: up to 20 minutes (end of BLS-CPR)
Face mask leakage
face mask leakage per ventilation procedure
Measured: up to 20 minutes (end of BLS-CPR)
Volume received by the patient
Volume received (mL) by the patient per ventilation procedure
Measured: up to 20 minutes (end of BLS-CPR)
Survival to day 60 after cardiac arrest
Survival curve over the first 60 days
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start26 May 2023
- Primary completion1 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Arrest, Out-Of-HospitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Defence Health Service
- Sponsor type
- Other government
- Collaborators
- Fire Brigade Of Paris Emergency Medicine Dept
- Responsible party
- Principal investigator, Daniel Jost, Fire Brigade Of Paris Emergency Medicine Dept
- Investigators
- Frederic Lemoine, NP, Principal investigator, Paris Fire Brigade Emergency DeptStephane Travers, MD PhD, Study chair, Paris Fire Brigade Emergency Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992454
- Sponsor's protocol ID
- 2022-A02771-42
- Acronym
- VECARS
- Status last verified
- Feb 2024
- First submitted
- 6 Jul 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lemoine F, Jost D, Lemoine S, Petermann A, Salome M, Tassart B, Liscia J, Briche F, Bon O, Derkenne C, Frattini B, Travers S; Paris Fire Brigade Cardiac Arrest Task Force (collaborators). Manual bag-valve-mask ventilation during out-of-hospital cardiopulmonary resuscitation: a prospective observational study. Resuscitation. 2025 Dec;217:110895. doi: 10.1016/j.resuscitation.2025.110895. Epub 2025 Nov 12.
PubMed 41237844
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Manual Ventilation Practices of Professional Firefighters During Cardiopulmonary Resuscitation.
- ClinicalTrials.gov ID
- NCT05992454
- Acronym / sponsor ID
- VECARS / 2022-A02771-42
- Keywords
- heart arrest, cardiopulmonary resuscitation, bag-valve-mask, rescuers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- French Defence Health ServiceOther government
- Collaborators
- Fire Brigade Of Paris Emergency Medicine Dept
- Study start
- 26 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Civilian population in hyperurban areas
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- trauma related OHCA
- airway obstruction during CPR
- OHCA on hanging
- tracheostomized patient
- obstacle to using the Bag-valve-mask
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOLIFEMeasurement of ventilatory parameters during manual ventilation by professional rescuers during out-of-hospital cardiac arrest | Device | – |
Primary outcome
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
6 secondary outcomes
chest rise
Time frame: up to 20 minutes (end of BLS-CPR)
Ventilation rate
Time frame: up to 20 minutes (end of BLS-CPR)
Insufflation time
Time frame: up to 20 minutes (end of BLS-CPR)
Face mask leakage
Time frame: up to 20 minutes (end of BLS-CPR)
Volume received by the patient
Time frame: up to 20 minutes (end of BLS-CPR)
Survival to day 60 after cardiac arrest
Time frame: up to 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 41237844Lemoine F, Jost D, Lemoine S, Petermann A, Salome M, Tassart B, Liscia J, Briche F, Bon O, Derkenne C, Frattini B, Travers S; Paris Fire Brigade Cardiac Arrest Task Force (collaborators). Manual bag-valve-mask ventilation during out-of-hospital cardiopulmonary resuscitation: a prospective observational study. Resuscitation. 2025 Dec;217:110895. doi: 10.1016/j.resuscitation.2025.110895. Epub 2025 Nov 12.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Lemoine, NP principal investigator
Paris Fire Brigade Emergency Dept
Stephane Travers, MD PhD study chair
Paris Fire Brigade Emergency Dept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest, Out-Of-Hospital and CardioPulmonary Resuscitation, run by French Defence Health Service at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: up to 20 minutes (end of BLS-CPR)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05992454, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.