Actively Recruiting
Drowning-related Acute Respiratory Failure
Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-06
210
Participants Needed
9
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Drowning-related Acute Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Man/boy or woman/girl, 1 year old and older
- Diagnosed with drowning-related acute respiratory failure
- Capillary oxygen saturation below 92% at first Emergency Medical Service assessment
- Requires oxygen supply at 15 liters per minute to maintain oxygen saturation of 95% or higher
- Shows at least one clinical sign of acute respiratory failure: respiratory rate over 30/min, sternal or clavicular indrawing, abdominal breathing, or cyanosis
- Affiliated with or beneficiary of a French health insurance system
- Able to benefit from both treatment strategies
- Adults have signed informed consent; children have parental authorization
You will not qualify if you...
- Body temperature 34°C or lower (hypothermia)
- Neurological distress with Glasgow Coma Scale less than 13 at first assessment or during first 15 minutes of care
- Hemodynamic distress with systolic blood pressure below 90 mmHg at first assessment or during first 15 minutes of care
- Cardiac arrest or respiratory arrest
- Declared pregnancy or breastfeeding
- Under legal protection regime for adults
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Centre Hospitalier de la Côte Basque - Urgences
Bayonne, France
Actively Recruiting
2
Groupe Hospitalier PELLEGRIN - SAMU-SMUR
Bordeaux, France
Actively Recruiting
3
CH La Rochelle - Urgence
La Rochelle, France
Actively Recruiting
4
Centre Hospitalier Côte de Lumière - SAMU/SMUR 85
Les Sables-d'Olonne, France
Actively Recruiting
5
CHU Timone - APHM
Marseille, France, 13005
Not Yet Recruiting
6
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France
Actively Recruiting
7
CHU de Nantes - Urgences/SAMU
Nantes, France
Actively Recruiting
8
CHU Nice Hôpital Pasteur
Nice, France
Actively Recruiting
9
CHITS Hôpital Ste Musse
Toulon, France, 83053
Actively Recruiting
Research Team
P
Pierre Michelet, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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