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New ventilator strategy for obese ARDS patients under study

NCT ID NCT06119516

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether using a special tube to measure pressure inside the chest can help doctors set breathing machines better for severely obese patients with acute lung injury. About 40 adults with a BMI over 40 and moderate to severe ARDS will take part. The goal is to see if this personalized method leads to different and possibly better ventilator settings than the standard approach.

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 40 people

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

Started

Apr 2024

Expected to finish

Jul 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: * Adult patient (aged 18 years or older) * Class III morbid obesity (BMI \> 40 kg/m2) * Moderate or severe ARDS criteria (according to the Berlin definition) * Less than 72 hours between fulfilling moderate or severe ARDS criteria and inclusion * Tracheal intubation and invasive mechanical ventilation * Informed consent (patient, next of kin), with possibility of an emergency procedure with deferred consent * Covid-19 and non-Covid-19 patients Exclusion Criteria: * Contra-indication to nasogastric tube (uncontrolled coagulopathy, severe thrombocytopenia, nasal trauma, esophageal varices) * Order to limit life-sustaining therapy * ExtraCorporal Membrane Oxygenation (ECMO) in use * Invasive mechanical ventilation \> 96 hours * Elevated intracranial pressure * Active air-leak: pneumothorax, pneumomediastinum * Pregnancy or breast feeding * Patient on state medical aid

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome morbid obesity

As listed by the trial registrant

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

ARDS, human Obesity, morbid

How to take part

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

  1. The places running it

    5 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

  • AP-HP, Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, 75015, France

  • CHU Angers

    RECRUITING

    Angers, 49933, France

  • CHU la Milétrie

    RECRUITING

    Poitiers, 86021, France

  • Hôpital Bicêtre, AP-HP

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital de la Croix-Rousse, HCL

    RECRUITING

    Lyon, 69004, France

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