Observational Study of Drowning Patient's Emergency Care in Its Pre-hospital Phase. (VAR-NOYADE)

January 23, 2026 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Var
      • Toulon, Var, France, 83056
        • Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Drowning patient
  2. Aged 18 years old or over
  3. Patient treated by pre-hospital care from the emergency medical services 83 (SAMU 83) between 1st January 2019 and 30th September 2022.

Exclusion Criteria:

  1. Diving accident
  2. Patient opposition to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Drowning patients
Process of experiencing respiratory impairment from submersion/immersion in liquid
Other: Prehospital care following drowning accident
Prehospital care provided by the emergency medical service 83 (SAMU 83)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3-year period from 2019-2022
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
3-year period from 2019-2022
Pre-hospital intervention duration
Time Frame: 3-year period from 2019-2022
In minutes
3-year period from 2019-2022
Type of resources involved for pre-hospital care
Time Frame: 3-year period from 2019-2022
None, fire brigade or emergency rapid response unit
3-year period from 2019-2022

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Onset of death
Time Frame: Up to 30 days
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).
Up to 30 days
Duration of hospitalisation
Time Frame: Up to 30 days
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).
Up to 30 days
Intubation rate at hospital
Time Frame: Up to 30 days
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).
Up to 30 days
Type of ventilation used at hospital
Time Frame: Up to 30 days
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).
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Célia BOUTIN, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-CHITS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drowning

Clinical Trials on Prehospital care following drowning accident

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings