Actively Recruiting
Study of Non-Invasive Ventilation with Continuous Positive Airway Pressure Compared to Oxygen Face Mask for Treating Drowning-Related Acute Respiratory Failure
Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-06
210
Participants Needed
9
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of Non-Invasive Ventilation using Continuous Positive Airway Pressure CPAP compared to oxygen supply by face mask for treating acute respiratory failure caused by drowning. The study is an open-label, multicenter, prospective, cross-over cluster randomized trial conducted in 16 emergency medical centers in France. It addresses the urgent need for clearer treatment guidelines, as no national or international consensus currently exists for managing drowning-related acute respiratory failure. Participants receive one of two treatments the experimental group receives non-invasive ventilation with CPAP set between 8 to 10 cm H2O starting from the pre-hospital setting through to intensive care unit admission and continuing until 6 hours after the start of drowning care. The control group receives oxygen supply by face mask at 15 liters per minute for the same time period. Both treatments are continued in the intensive care unit until the respiratory failure improves, with gradual weaning based on maintaining oxygen saturation levels. During the study, participants are closely monitored for oxygen saturation, neurological status using the Glasgow Coma Scale, blood pressure, occurrence of cardiac arrest, and aspiration within the first 6 hours after treatment begins. The emergency medical teams may decide on mechanical ventilation if needed. The trial aims to observe the ability to improve oxygen saturation above 92% and maintain a stable neurological and cardiovascular status. The total involvement includes pre-hospital care and intensive care monitoring during the critical early hours following drowning.
CONDITIONS
Brief Title
Drowning-related Acute Respiratory Failure
Research Team
P
Pierre Michelet, MD
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