Drowning-related Acute Respiratory Failure — CPAPDROWNING  

Drowning Clinical Trial

Official title: Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for 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. ;

Related Conditions & MeSH terms

• Drowning
• Respiratory Insufficiency

• 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