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RECRUITING
NCT06183827
NA

Drowning-related Acute Respiratory Failure

Sponsor: Assistance Publique Hopitaux De Marseille

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the Non-Invasive Ventilation-Continuous Positive Airway Pressure efficacy (experimental group) for drowning related Acute Respiratory Failure compared to Oxygen Supply by face mask (15Liters/minutes) (control group).

Official title: Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure

Key Details

Gender

All

Age Range

1 Year - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2024-07-24

Completion Date

2027-03

Last Updated

2026-02-06

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Emergency Medical Service intervention : Oxygen Supply strategy

During the 4-month period of control, the care teams will: \- Use Oxygen Supply by face mask (15Liters/minutes) from pre-hospital to intensive care unit admission until the 6th hour following the start of drowning care (Emergency Medical Service arrival at the scene). Indeed, current concepts of advanced prehospital care include the use of oxygen by face mask (15Liters/minutes) and intubation-Mechanical Ventilation in case of failure. The requirement of intubation-Mechanical Ventilation by the Emergency Medical Service (pre-hospital phase) or Intensive Care Unit (hospital phase) practitioners during this first 6 hours period will be left to the discretion of the practitioners in charge of the patient; \- Continue this strategy in the Intensive Care Unit until the Acute Respiratory Failure resolution allows a reduction of Oxygen Supply. The Oxygen Supply will be reduced progressively litter by litter each 12 hours period with maintenance of capillary saturation up to 92%.

PROCEDURE

Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy

During the 4-month period of experimentation, the care teams will: \- Use Non-Invasive Ventilation by Continuous Positive Airway Pressure (set between 8 to 10 cm H2O) from pre-hospital setting to Intensive Care Unit admission until the 6th hour following the start of drowning care (Emergency Medical Service arrival at the scene). The requirement of Mechanical Ventilation by the Emergency Medical Service (pre-hospital phase) or Intensive Care Unit (hospital phase) practitioners during this first 6 hours period will be left to the discretion of the practitioners in charge of the patient. \- Continue this strategy in the Intensive Care Unit until the Acute Respiratory Failure resolution allows a reduction of Non-Invasive Ventilation-Continuous Positive Airway Pressure. Non-Invasive Ventilation-Continuous Positive Airway Pressure support will be weaned progressively (left at practitioners' convenience) with maintenance of capillary O2 saturation up to 92%.

Locations (9)

Centre Hospitalier de la Côte Basque - Urgences

Bayonne, France

Groupe Hospitalier PELLEGRIN - SAMU-SMUR

Bordeaux, France

CH La Rochelle - Urgence

La Rochelle, France

Centre Hospitalier Côte de Lumière - SAMU/SMUR 85

Les Sables-d'Olonne, France

CHU Timone - APHM

Marseille, France

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, France

CHU de Nantes - Urgences/SAMU

Nantes, France

CHU Nice Hôpital Pasteur

Nice, France

CHITS Hôpital Ste Musse

Toulon, France