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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05751655
Other study ID # 2023-CHITS-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 18, 2023
Est. completion date June 13, 2023

Study information

Verified date March 2024
Source Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 296
Est. completion date June 13, 2023
Est. primary completion date June 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Prehospital care following drowning accident
Prehospital care provided by the emergency medical service 83 (SAMU 83)

Locations

Country Name City State
France Centre Hospitalier Intercommunal Toulon La Seyne sur Mer Toulon Var

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type of ventilation used in pre-hospital care Mechanical ventilation, non-invasive ventilation, Continuous Positive Airway Pressure, oxygen therapy or none 3-year period from 2019-2022
Primary Ventilatory settings used in pre-hospital care Positive End Expiratory Pressure, pressure support, fraction of inspired oxygen, flow rate 3-year period from 2019-2022
Primary Pre-hospital intervention duration In minutes 3-year period from 2019-2022
Primary Type of resources involved for pre-hospital care None, fire brigade or emergency rapid response unit 3-year period from 2019-2022
Secondary 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). Up to 30 days
Secondary 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). Up to 30 days
Secondary 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). Up to 30 days
Secondary 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). Up to 30 days
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