Treating severe breathing problems after drowning

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

This trial tests whether non-invasive ventilation using continuous positive airway pressure (CPAP) helps people of all ages with severe breathing problems after drowning better than high-flow oxygen delivered by face mask.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 1 Year and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (Academic / other)
• Locations: 9 sites (Bayonne and 8 other locations)
• Trial ID: NCT06183827 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, prospective cluster-randomized crossover trial run in 16 emergency medical service centers across France. Participating EMS centers are assigned to provide either CPAP non-invasive ventilation or oxygen by face mask at 15 L/min, then switch according to the crossover design. Patients aged 1 year and older who present after drowning with oxygen saturation <92% and clinical signs of acute respiratory failure are enrolled. The study compares short-term oxygenation, need for intubation or mechanical ventilation, neurological status, and mortality between the two strategies.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 1 year and older in France who present after drowning with SpO2 <92% requiring 15 L/min to reach ≥95% and at least one clinical sign of respiratory failure, and who have no contraindication to either strategy.

Not a fit: Patients who are hemodynamically unstable, require immediate intubation, have contraindications to non-invasive ventilation, are under 1 year old, or are not treated at a participating French EMS center are unlikely to benefit from this trial.

Why it matters

Potential benefit: If CPAP is superior, patients could restore oxygen levels faster, reduce the need for mechanical ventilation, and experience fewer complications or deaths after drowning.

How similar studies have performed: Retrospective case series and observational reports suggest CPAP may improve oxygenation after drowning, but no randomized head-to-head trials have confirmed this benefit.

Eligibility criteria

Inclusion Criteria:

* Man/boy or woman/girl, 1yo and older.
* Subject suffering from drowning related-Acute Respiratory Failure (whatever the nature of water, salt or fresh) and benefiting from the Emergency Medical Service intervention;
* Acute Respiratory Failure defined as the presence of:

  * Capillary O2 saturation \<92% upon Emergency Medical Service first clinical analysis at the drowning scene;
  * Need for oxygen supply 15Liters/minutes to reach capillary O2 saturation ≥ 95%;
  * Combination of Acute Respiratory Failure clinical signs: at least 1 of the following items: respiratory rate \>30/min, sternal or clavicular indrawing, abdominal breathing, cyanosis.
* Individual affiliated to or beneficiary of a French health insurance system;
* Individual with the ability to benefit from the two strategies (ambivalence clause);
* Adult Individual having signed written informed consent or child subject with an authorization of the parents.

Exclusion Criteria:

* Individual with hypothermia ≤ 34°C ;
* Individual with neurological distress defined by a Glasgow Coma Scale \< 13 at first clinical assessment and during the first 15 minutes of care ;
* Individual with hemodynamic distress defined by a systolic blood tension \< 90 mmHg at first clinical assessment and during the first 15 minutes of care ;
* Cardiac arrest or respiratory arrest ;
* Declared pregnancy or breastfeeding ;
* Patient under legal protection regime for adults.

Where this trial is running

Bayonne and 8 other locations

• Centre Hospitalier de la Côte Basque - Urgences — Bayonne, France (Recruiting)
• Groupe Hospitalier PELLEGRIN - SAMU-SMUR — Bordeaux, France (Recruiting)
• CH La Rochelle - Urgence — La Rochelle, France (Recruiting)
• Centre Hospitalier Côte de Lumière - SAMU/SMUR 85 — Les Sables-d'Olonne, France (Recruiting)
• CHU Timone - APHM — Marseille, France (Not_yet_recruiting)
• CHU de Montpellier - Hôpital Lapeyronie — Montpellier, France (Recruiting)
• CHU de Nantes - Urgences/SAMU — Nantes, France (Recruiting)
• CHU Nice Hôpital Pasteur — Nice, France (Recruiting)
• CHITS Hôpital Ste Musse — Toulon, France (Recruiting)

Study contacts

• Study coordinator: Pierre Michelet, MD

Conditions Drowning