Treating severe breathing problems after drowning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 de Montpellier - Hôpital Lapeyronie
  Montpellier, France Recruiting
• CHU de Nantes - Urgences/SAMU
  Nantes, France Recruiting

Study contacts

• Study coordinator: Pierre Michelet, MD
• Email: pierre.michelet@ap-hm.fr
• Phone: 638741313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.