DrowningVAR-NOYADENCT05751655
Observational Study of Drowning Patient's Emergency Care in Its Pre-hospital Phase.
An observational study of Drowning, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
According to the 9th edition of "NOYADES" survey, 1480 drownings accidents occurred in France in 2021, of which 146 (i.e. nearly 10%), were in the Var department. These patient's care involve in first place the Emergency Medical Service (EMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drowning
- What is being tested?
- Prehospital care following drowning accident
- How many people
- 296 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2023to 13 Jun 2023
- 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: Adult drowning patient treated by pre-hospital care from the emergency medical services 83 (SAMU 83) between 1st January 2019 and 30th September 2022.
Who may be able to join
- Drowning patient
- Aged 18 years old or over
- Patient treated by pre-hospital care from the emergency medical services 83 (SAMU 83) between 1st January 2019 and 30th September 2022.
Who cannot join
- Diving accident
- Patient opposition to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83056
About this study
According to the 9th edition of "NOYADES" survey, 1480 drownings accidents occurred in France in 2021, of which 146 (i.e. nearly 10%), were in the Var department. These patient's care involve in first place the Emergency Medical Service (EMS).
To date, there is no recommendation from French or European academic societies of emergency medicine formalising pre-hospital care of these patients (except for the specific case of cardiac arrest). This absence of recommendation therefore favours heterogeneity of practices.
Read the detailed description
Within a three-year period from 2019 to 2022, this retrospective observational study aims to provide an inventory of pre-hospital practices by the EMS in the Var department and to describe drowning patients' characteristics as well as their outcome, according to the initial regulation and the type of care. These data could help for pre-hospital care management.
- Conditions
- Drowning
- Being tested
- Prehospital care following drowning accident
- Keywords
- Drowning, Emergency medical service, Pre-hospital care, Patient outcome
- Medical subject headings
- Drowning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehospital care following drowning accidentOther
Prehospital care provided by the emergency medical service 83 (SAMU 83)
| Study group | Role | What they receive |
|---|---|---|
| Drowning patients | Process of experiencing respiratory impairment from submersion/immersion in liquid Receives: Other: Prehospital care following drowning accident |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of ventilation used in pre-hospital care
Mechanical ventilation, non-invasive ventilation, Continuous Positive Airway Pressure, oxygen therapy or none
Measured: 3-year period from 2019-2022
Ventilatory settings used in pre-hospital care
Positive End Expiratory Pressure, pressure support, fraction of inspired oxygen, flow rate
Measured: 3-year period from 2019-2022
Pre-hospital intervention duration
In minutes
Measured: 3-year period from 2019-2022
Type of resources involved for pre-hospital care
None, fire brigade or emergency rapid response unit
Measured: 3-year period from 2019-2022
Secondary outcomes (4)
Onset of death
Analysis according to the orientation provided by the EMS regulation (emergency rapid response unit or fire brigade) and according to the different types of care by the EMS (Oxygen therapy, non-invasive ventilation or intubation).
Measured: Up to 30 days
Duration of hospitalisation
Analysis according to the orientation provided by the EMS regulation (emergency rapid response unit or fire brigade) and according to the different types of care by the EMS (Oxygen therapy, non-invasive ventilation or intubation).
Measured: Up to 30 days
Intubation rate at hospital
Analysis according to the orientation provided by the EMS regulation (emergency rapid response unit or fire brigade) and according to the different types of care by the EMS (Oxygen therapy, non-invasive ventilation or intubation).
Measured: Up to 30 days
Type of ventilation used at hospital
Analysis according to the orientation provided by the EMS regulation (emergency rapid response unit or fire brigade) and according to the different types of care by the EMS (Oxygen therapy, non-invasive ventilation or intubation).
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start18 Jan 2023
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
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 DrowningStudies 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
- Retrospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Célia BOUTIN, MD, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751655
- Sponsor's protocol ID
- 2023-CHITS-002
- Acronym
- VAR-NOYADE
- Status last verified
- Nov 2025
- First submitted
- 10 Feb 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mathais Q, Jurain L, Sebai A, Mattei P, Jammes D, Kaidomar M, Kleiner G, Rammal F, Marquer B, Bertrand PM, Belloni A, Benner P, Meaudre E, Vergne M, Chelly J, Boutin C. Prehospital factors associated with ICU admission in drowning patients: a retrospective multicenter cohort study in a French coastal region. BMC Emerg Med. 2026 Jan 20;26(1):54. doi: 10.1186/s12873-026-01481-3.
PubMed 41559630
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Drowning Patient's Emergency Care in Its Pre-hospital Phase.
- ClinicalTrials.gov ID
- NCT05751655
- Acronym / sponsor ID
- VAR-NOYADE / 2023-CHITS-002
- Conditions
- Drowning
- Keywords
- Drowning, Emergency medical service, Pre-hospital care, Patient outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 2 Mar 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.
According to the 9th edition of "NOYADES" survey, 1480 drownings accidents occurred in France in 2021, of which 146 (i.e. nearly 10%), were in the Var department. These patient's care involve in first place the Emergency Medical Service (EMS).
To date, there is no recommendation from French or European academic societies of emergency medicine formalising pre-hospital care of these patients (except for the specific case of cardiac arrest). This absence of recommendation therefore favours heterogeneity of practices.
Detailed description
Within a three-year period from 2019 to 2022, this retrospective observational study aims to provide an inventory of pre-hospital practices by the EMS in the Var department and to describe drowning patients' characteristics as well as their outcome, according to the initial regulation and the type of care. These data could help for pre-hospital care management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drowning patients | – | Other: Prehospital care following drowning accidentProcess of experiencing respiratory impairment from submersion/immersion in liquid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult drowning patient treated by pre-hospital care from the emergency medical services 83 (SAMU 83) between 1st January 2019 and 30th September 2022.
Key inclusion criteria (3 listed)
- Drowning patient
- Aged 18 years old or over
- Patient treated by pre-hospital care from the emergency medical services 83 (SAMU 83) between 1st January 2019 and 30th September 2022.
Key exclusion criteria (2 listed)
- Diving accident
- Patient opposition to participate in the study
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 |
|---|---|---|
| Prehospital care following drowning accidentPrehospital care provided by the emergency medical service 83 (SAMU 83) | Other | Drowning patients |
Primary outcome
Type of ventilation used in pre-hospital care
Time frame: 3-year period from 2019-2022
Mechanical ventilation, non-invasive ventilation, Continuous Positive Airway Pressure, oxygen therapy or none
Ventilatory settings used in pre-hospital care
Time frame: 3-year period from 2019-2022
Positive End Expiratory Pressure, pressure support, fraction of inspired oxygen, flow rate
Pre-hospital intervention duration
Time frame: 3-year period from 2019-2022
In minutes
Type of resources involved for pre-hospital care
Time frame: 3-year period from 2019-2022
None, fire brigade or emergency rapid response unit
4 secondary outcomes
Onset of death
Time frame: Up to 30 days
Duration of hospitalisation
Time frame: Up to 30 days
Intubation rate at hospital
Time frame: Up to 30 days
Type of ventilation used at hospital
Time frame: Up to 30 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 26 Jan 2026.
- Results publication: PubMed 41559630Mathais Q, Jurain L, Sebai A, Mattei P, Jammes D, Kaidomar M, Kleiner G, Rammal F, Marquer B, Bertrand PM, Belloni A, Benner P, Meaudre E, Vergne M, Chelly J, Boutin C. Prehospital factors associated with ICU admission in drowning patients: a retrospective multicenter cohort study in a French coastal region. BMC Emerg Med. 2026 Jan 20;26(1):54. doi: 10.1186/s12873-026-01481-3.
- Individual participant dataSharing planned: No
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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.
Célia BOUTIN, MD study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
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 Drowning, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer 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 3 inclusion and 2 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 26 Jan 2026. 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?
Type of ventilation used in pre-hospital care (time frame: 3-year period from 2019-2022). The study lists 4 primary outcomes in all. 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 NCT05751655, 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 26 Jan 2026.