Actively Recruiting

Phase Not Applicable
Age: 1Year +
All Genders
NCT06183827

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

Age: 1Year +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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