- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05751655
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Var
-
Toulon, Var, France, 83056
- Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Diving accident
- Patient opposition to participate in the study
Study Plan
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
Investigators
- Study Director: Célia BOUTIN, MD, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-CHITS-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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