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Breathing battle: which oxygen method saves more lives after ICU extubation?

NCT ID NCT05686850

Disease control Sponsor: Poitiers University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at two ways to help ICU patients who struggle to breathe after their breathing tube is taken out. About 670 adults will be randomly assigned to receive either a non-invasive ventilation mask alternating with high-flow nasal oxygen, or high-flow nasal oxygen alone. The goal is to see which approach lowers the chance of death within 28 days.

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 670 people

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

Started

Feb 2023

Expected to finish

Aug 2028

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

18 years 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: * Duration of invasive mechanical ventilation of more than 24h in the ICU before extubation. * Post-extubation respiratory failure occurring within the first 7 days after extubation (see criteria below). As in several previous studies, post-extubation respiratory failure will be defined by the presence of the 2 following criteria combining a clinical criterion and a blood gas criterion: * Clinical criterion persisting for at least 30 minutes: a respiratory rate exceeding 25 breaths per minute or clinical signs of respiratory distress with increased accessory muscle activity. * Blood gas criterion: Hypoxemia defined as PaO2/FiO2 ratio below 150 mm Hg or respiratory acidosis defined as pH below 7.35 units and PaCO2 above 45 mm Hg. For patients under standard oxygen, FiO2 will calculated according to the following formula: FiO2 = 0.21 + 0.03 x (oxygen flow L/min). * Informed consent from the relatives or the patient himself, or emergency inclusion procedure in case of inability of patient or proxy to give consent. Exclusion Criteria: * NIV at home * ICU admission for peripheral neuromuscular disease type Guillain-Barré syndrome or myasthenia gravis. * Upper airway obstruction as main reason for post-extubation respiratory failure * Urgent need for reintubation (respiratory or cardiac arrest, respiratory pauses with loss of consciousness or gasping for air, or severe hypoxemia defined as SpO2 lower than 90% despite maximal oxygen support) * Altered consciousness (Glasgow coma scale \< 12) * Unplanned extubation (accidental or self-extubation) * Do-not-reintubate order at time of respiratory failure * Patient previously included in the study * People under protection (minors, persons deprived of liberty by a judicial or administrative decision, adults under law protection) * Patient not affiliated to health care system.

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Conditions

The condition(s) this trial relates to.

respiratory failure

As listed by the trial registrant

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

Post extubation respiratory failure

How to take part

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

  1. The places running it

    42 sites in 4 countries. 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

  • André Mignot Hospital

    RECRUITING

    Le Chesnay, France

  • Angers University Hospital

    RECRUITING

    Angers, France

  • Bordeaux University Hospital

    WITHDRAWN

    Bordeaux, France

  • Brest University Hospital

    RECRUITING

    Brest, France

  • Clermont-Ferrand University Hospital

    RECRUITING

    Clermont-Ferrand, France

  • Complejo Hospitalario Universitario de Toledo

    TERMINATED

    Toledo, Spain

  • Cèdres Clinic

    RECRUITING

    Cornebarrieu, France

  • Dax Hospital

    WITHDRAWN

    Dax, France

  • Emile Muller Hospital

    RECRUITING

    Mulhouse, France

  • Erasme Hospital

    RECRUITING

    Brussels, Belgium

  • Felix Guyon Hospital

    TERMINATED

    Saint-Denis, Reunion

  • Fleyriat Hospital

    RECRUITING

    Bourg-en-Bresse, France

  • Foch Hospital

    RECRUITING

    Suresnes, France

  • Francois Mitterrand Hospital

    RECRUITING

    Dijon, France

  • Grenoble University Hospital

    RECRUITING

    Grenoble, France

  • Henri Duffaut Hospital

    RECRUITING

    Avignon, France

  • Henri Mondor Hospital

    RECRUITING

    Aurillac, France

  • Henri Mondor Hospital

    RECRUITING

    Créteil, France

  • Hospital Universitari de Bellvitge

    NOT_YET_RECRUITING

    L'Hospitalet de Llobregat, Spain

  • Hospital Universitario Central de Asturias

    NOT_YET_RECRUITING

    Oviedo, Spain

  • Hospital de La Santa Creu I Sant Pau

    NOT_YET_RECRUITING

    Barcelona, Spain

  • La Pitié Salpêtrière Hospital

    RECRUITING

    Paris, France

  • La Rochelle Hospital

    RECRUITING

    La Rochelle, France

  • La Timone Hospital

    RECRUITING

    Marseille, France

  • Le Mans Hospital

    RECRUITING

    Le Mans, France

  • Lens Hospital

    RECRUITING

    Lens, France

  • Lille University Hospital

    RECRUITING

    Lille, France

  • Limoges University Hospital

    RECRUITING

    Limoges, France

  • Louis Mourier Hospital

    RECRUITING

    Colombes, France

  • Mont de Marsan Hospital

    WITHDRAWN

    Mont-de-Marsan, France

  • Moulins-Yzeure Hospital

    RECRUITING

    Moulins, France

  • Nantes University Hospital

    RECRUITING

    Nantes, France

  • Nice University Hospital

    RECRUITING

    Nice, France

  • Nord-Franche-Comté Hospital

    RECRUITING

    Belfort, France

  • Orléans University Hospital

    RECRUITING

    Orléans, France

  • Pau Hospital

    RECRUITING

    Pau, France

  • Pierre Zobda Quitman Hospital

    RECRUITING

    Fort-de-France, Martinique

  • Poitiers University Hospital

    RECRUITING

    Poitiers, France

  • Rennes University Hospital

    RECRUITING

    Rennes, France

  • Rouen University Hospital

    RECRUITING

    Rouen, France

  • Saint Joseph Saint Luc Hospital

    RECRUITING

    Lyon, France

  • Saint Nazaire Hospital

    RECRUITING

    Saint-Nazaire, France

  • Saintes Hospital

    RECRUITING

    Saintes, France

  • Tours University Hospital

    RECRUITING

    Tours, France

  • Vannes Hospital

    RECRUITING

    Vannes, France

  • Vendée Hospital

    RECRUITING

    La Roche-sur-Yon, France

  • Victor Dupouy Hospital

    RECRUITING

    Argenteuil, France