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Could a breathing mask save drowning patients from a breathing tube?

NCT ID NCT06183827

Disease control Sponsor: Assistance Publique Hopitaux De Marseille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether non-invasive ventilation (a breathing mask that pushes air into the lungs) works better than standard oxygen masks for people who nearly drowned and have trouble breathing. Researchers will compare how many patients in each group need a breathing tube (intubation) within the first 6 hours. The trial includes 210 children and adults treated by emergency medical services.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Non-invasive ventilation (CPAP) and oxygen therapy via face mask
What this could lead to
If it works, this could show that CPAP helps drowning patients avoid needing a breathing tube, potentially reducing complications and improving recovery.
What could go wrong
This is a relatively small, early-stage study (210 participants) comparing two emergency procedures. Results may not apply to all drowning cases, and CPAP might not prevent intubation in severe situations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Drowning

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drowning

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH La Rochelle - Urgence

    RECRUITING

    La Rochelle, France

  • CHITS Hôpital Ste Musse

    RECRUITING

    Toulon, 83053, France

  • CHU Nice Hôpital Pasteur

    RECRUITING

    Nice, France

  • CHU Timone - APHM

    NOT_YET_RECRUITING

    Marseille, 13005, France

  • CHU de Montpellier - Hôpital Lapeyronie

    RECRUITING

    Montpellier, France

  • CHU de Nantes - Urgences/SAMU

    RECRUITING

    Nantes, France

  • Centre Hospitalier Côte de Lumière - SAMU/SMUR 85

    RECRUITING

    Les Sables-d'Olonne, France

  • Centre Hospitalier de la Côte Basque - Urgences

    RECRUITING

    Bayonne, France

  • Groupe Hospitalier PELLEGRIN - SAMU-SMUR

    RECRUITING

    Bordeaux, France

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