Drowning-related Acute Respiratory Failure

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial Description

Open-label, multicenter, prospective, cross-over cluster randomized (ratio 1:1), conducted in 16 Emergency Medical Service centers in France : - Experimental group: Non-Invasive Ventilation-Continuous Positive Airway Pressure (Arm 1) - Control group: Oxygen Supply by face mask (Arm 2) Drowning-related acute respiratory failure has important clinical consequences (4 to 18% mortality). No national/international medical consensus exist for its management. Our team has successively demonstrated that: - The acute respiratory failure related to drowning in salt or fresh water presented the same clinical pathway and prognosis ; - Most victims with drowning related acute respiratory failure do no present hemodynamic instability ; - If the oxygenation is rapidly improved, neurological status is also maintained in acute respiratory failure victims ; - Pediatric and adult presentations are similar. Facing an acute respiratory failure, emergency medical service must rapidly choose between oxygen supply by face mask (15 liters /minutes), mechanical ventilation or non-invasive ventilation. mechanical ventilation as non-invasive ventilation present interests and side arms. No comparative study has been conducted between these strategies. The arguments for non-invasive ventilation use specifically in a continuous positive airway pressure mode are: - Fast recovery of acute respiratory failure in 24h - Retrospective publications showing that the benefit of non-invasive ventilation probably based on continuous positive airway pressure mode - Easy implementation of continuous positive airway pressure in the pre-hospital setting (adults, children, newborns) - Complexity of mechanical ventilation in pre-hospital setting. Our working hypothesis is the efficacy of early use of non-invasive ventilation-continuous positive airway pressure in drowning related acute respiratory failure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06183827
Study type	Interventional
Source	Assistance Publique Hopitaux De Marseille
Contact	Pierre Michelet, MD
Phone	638741313
Email	pierre.michelet@ap-hm.fr
Status	Not yet recruiting
Phase	N/A
Start date	April 2024
Completion date	March 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Drowning-related Acute Respiratory Failure — CPAPDROWNING

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms