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

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

Completed

Conditions

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

Observational

Enrollment (Actual)

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

    • 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

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
Intervention / Treatment
Drowning patients
Process of experiencing respiratory impairment from submersion/immersion in liquid
Prehospital care provided by the emergency medical service 83 (SAMU 83)

What is the study measuring?

Primary Outcome Measures

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

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.

Investigators

  • Study Director: Célia BOUTIN, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

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)

January 18, 2023

Primary Completion (Actual)

June 13, 2023

Study Completion (Actual)

June 13, 2023

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

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.

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