Actively Recruiting
Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure
Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-06
210
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of Non-Invasive Ventilation using Continuous Positive Airway Pressure (CPAP) compared to oxygen supply by face mask for treating acute respiratory failure caused by drowning. The study is an open-label, multicenter, prospective, cross-over cluster randomized trial conducted in 16 emergency medical centers in France. It addresses the urgent need for clearer treatment guidelines, as no national or international consensus currently exists for managing drowning-related acute respiratory failure. Participants receive one of two treatments: the experimental group receives non-invasive ventilation with CPAP set between 8 to 10 cm H2O starting from the pre-hospital setting through to intensive care unit admission and continuing until 6 hours after the start of drowning care. The control group receives oxygen supply by face mask at 15 liters per minute for the same time period. Both treatments are continued in the intensive care unit until the respiratory failure improves, with gradual weaning based on maintaining oxygen saturation levels. During the study, participants are closely monitored for oxygen saturation, neurological status using the Glasgow Coma Scale, blood pressure, occurrence of cardiac arrest, and aspiration within the first 6 hours after treatment begins. The emergency medical teams may decide on mechanical ventilation if needed. The trial aims to observe the ability to improve oxygen saturation above 92% and maintain a stable neurological and cardiovascular status. The total involvement includes pre-hospital care and intensive care monitoring during the critical early hours following drowning.
CONDITIONS
Brief Title
Drowning-related Acute Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 1 year and older
- Suffering from drowning-related acute respiratory failure, regardless of salt or fresh water
- Capillary oxygen saturation below 92% at first clinical assessment on scene
- Requires oxygen supply at 15 liters per minute to reach oxygen saturation at or above 95%
- Shows at least one clinical sign of acute respiratory failure such as respiratory rate over 30 per minute, 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
- Adult participants must give written informed consent; children must have parental authorization
You will not qualify if you...
- Body temperature at or below 34°C (hypothermia)
- Neurological distress with Glasgow Coma Scale below 13 at initial assessment or during first 15 minutes of care
- Hemodynamic distress with systolic blood pressure below 90 mmHg at initial assessment or during first 15 minutes of care
- Cardiac or respiratory arrest
- Pregnant or breastfeeding individuals
- Patients under legal protection for adults
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 6 hours initially, with continued treatment duration depending on acute respiratory failure resolution
Participants receive either Non-Invasive Ventilation with Continuous Positive Airway Pressure or Oxygen Supply by face mask from the pre-hospital setting through intensive care unit admission until 6 hours after the start of drowning care. Treatment is continued and gradually reduced in the intensive care unit as acute respiratory failure resolves.
Continuous intervention during pre-hospital and intensive care phases; visit schedule depends on clinical care
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here