NCT06183827

Drowning-related Acute Respiratory Failure

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Drowning

Interventions

Type	Name	Description
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%.

Timeline

• Start date: 2024-07-24
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2023-12-28
• Last updated: 2026-02-06

Locations

9 sites across 1 country: France