Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New trial tests CPAP combo to save lives in breathing crisis

NCT ID NCT06213168

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares two oxygen therapy strategies for adults in the ICU with severe breathing failure. One group gets high-flow oxygen alone, the other gets high-flow oxygen plus CPAP sessions. The goal is to see if adding CPAP reduces the need for a breathing tube and lowers the risk of death within 90 days. About 1,084 participants will be enrolled.

What this could mean

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

Active substance
Continuous positive airway pressure (CPAP) and high-flow nasal cannula oxygen therapy
What this could lead to
If it works, this could show that adding CPAP to high-flow oxygen helps more people survive severe breathing failure without needing a breathing tube.
What could go wrong
This is a large trial, but earlier studies on CPAP for this condition have had mixed results. The treatment may not lower death rates and could cause discomfort or delays in needed intubation.

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 1,084 people

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

Started

Aug 2025

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

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: 1. Adults (≥ 18 years old) 2. Admitted in the ICU for ≤ 24 hours 3. De novo hARF defined by the three following criteria: 1. Respiratory rate \> 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration 2. PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered. 3. Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan 4. Informed consent from the patient or her/his next of kin or another substitute decision maker, or inclusion procedure in emergency if the patient is unable to consent Exclusion Criteria: 1. Refusal of study participation by the patient or the proxy 2. Anatomical factors precluding the use of a nasal cannula or CPAP 3. Long term oxygen 4. Home CPAP or NIV or CPAP or NIV initiated prior to ICU admission 5. Hypercapnia indicating NIV (PaCO2 \> 45 mmHg) 6. Isolated cardiogenic pulmonary oedema indicating NIV 7. Known pregnancy or breastfeeding 8. Absence of coverage by the French statutory health care insurance system (including AME) 9. Abdominal, thoracic or cardiac surgery within the last 6 days 10. Use of vasopressors (norepinephrine\>0.3 mcg/kg/min) 11. Glasgow coma scale \< 13 12. Urgent need for endotracheal intubation 13. Patients at an end-of-life stage receiving compational oxygenation 14. Exacerbation of a chronic respiratory disease 15. Legal protection (curatorship or tutorship) 16. Undrained pneumothorax

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for De novo hypoxemic acute respiratory failure (HARF) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute respiratory failure

As listed by the trial registrant

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

De novo hypoxemic acute respiratory failure (HARF)

How to take part

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

  1. The places running it

    28 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

  • APHP - hôpital Pitié-Salpêtrière

    RECRUITING

    Paris, 75013, France

  • CHU Amiens-Picardie

    NOT_YET_RECRUITING

    Amiens, 80054, France

  • CHU Angers

    NOT_YET_RECRUITING

    Angers, 49933, France

  • CHU de Nantes

    NOT_YET_RECRUITING

    Nantes, 44000, France

  • Centre Hospitalier Sud Francilien

    NOT_YET_RECRUITING

    Corbeil-Essonnes, 91100, France

  • Centre Hospitalier Victor Dupouy

    NOT_YET_RECRUITING

    Argenteuil, 95107, France

  • Centre Hospitalier de Bourg-en-Bresse - Site de Fleyriat

    RECRUITING

    Bourg-en-Bresse, 01012, France

  • Centre Hospitalier de Dieppe - Site Pasteur

    RECRUITING

    Dieppe, 76200, France

  • Centre Hospitalier du Mans

    RECRUITING

    Le Mans, 72037, France

  • Hôpital André Mignot

    RECRUITING

    Le Chesnay, 78157, France

  • Hôpital Avicenne

    NOT_YET_RECRUITING

    Bobigny, 93000, France

  • Hôpital Bicêtre

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Charles-Nicolle

    RECRUITING

    Rouen, 76000, France

  • Hôpital François Mitterrand

    RECRUITING

    Dijon, 21000, France

  • Hôpital Henri-Mondor

    RECRUITING

    Créteil, 94010, France

  • Hôpital Lapeyronie

    RECRUITING

    Montpellier, 34090, France

  • Hôpital Louis-Mourier

    NOT_YET_RECRUITING

    Colombes, 92700, France

  • Hôpital Lyon Sud - Hospices Civils de Lyon

    NOT_YET_RECRUITING

    Lyon, 69495, France

  • Hôpital Pasteur

    ACTIVE_NOT_RECRUITING

    Nice, 06000, France

  • Hôpital Pontchaillou

    NOT_YET_RECRUITING

    Rennes, 35000, France

  • Hôpital Saint-Antoine

    RECRUITING

    Paris, 75012, France

  • Hôpital Saint-Joseph Saint-Luc

    NOT_YET_RECRUITING

    Lyon, 69007, France

  • Hôpital Salengro

    RECRUITING

    Lille, 59037, France

  • Hôpital Tenon

    RECRUITING

    Paris, 75020, France

  • Hôpital de l'Archet

    RECRUITING

    Nice, 06200, France

  • Hôpital de la Croix-Rousse - Hospices Civils de Lyon

    RECRUITING

    Lyon, 69004, France

  • Hôpital la Milétrie

    NOT_YET_RECRUITING

    Poitiers, 86000, France

  • Hôpital Édouard Herriot - Hospices Civils de Lyon

    RECRUITING

    Lyon, 69003, France

  • Nouvel hôpital civil

    RECRUITING

    Strasbourg, 67000, France