Drowning-related Acute Respiratory Failure
Recruiting now · Not applicable
Conditions studied: Drowning
In brief
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).
Key facts
- Study ID
- NCT06183827
- Run by
- Assistance Publique Hopitaux De Marseille
- People needed
- 210
- Starts
- 2024-07-24
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-02-06
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Centre Hospitalier de la Côte Basque - Urgences — Bayonne, France (enrolling)
- Groupe Hospitalier PELLEGRIN - SAMU-SMUR — Bordeaux, France (enrolling)
- CH La Rochelle - Urgence — La Rochelle, France (enrolling)
- Centre Hospitalier Côte de Lumière - SAMU/SMUR 85 — Les Sables-d'Olonne, France (enrolling)
- CHITS Hôpital Ste Musse — Toulon, France (enrolling)
- CHU de Montpellier - Hôpital Lapeyronie — Montpellier, France (enrolling)
- CHU de Nantes - Urgences/SAMU — Nantes, France (enrolling)
- CHU Nice Hôpital Pasteur — Nice, France (enrolling)
- CHU Timone - APHM — Marseille, France
Full record on ClinicalTrials.gov
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