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Could 40 hours on your belly save more lives from lung failure?

NCT ID NCT07126964

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether keeping patients with severe lung failure (ARDS) on their stomachs for 40 hours at a time, instead of the usual 16 hours, can lower the chance of death. About 800 adults on breathing machines will be randomly assigned to one of the two positions. The goal is to see if the longer belly-down approach improves survival at 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 800 people

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

Started

Oct 2025

Expected to finish

Oct 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: Age of 18 years * Admitted to ICU. * Under invasive ventilation for a maximum of 5 days. * Meeting the 2012 Berlin criteria for ARDS * Protective ventilation at time of inclusion : 1. Plateau pressure \< 35 cm of H2O at the time of screening 2. VT ≤ 8 ml/kg PBW on all nurse's charts before inclusion 3. PEEP ≥ 5 cm H2O on all nurse's charts before inclusion c. Twice daily blood gas while FiO2 ≥ 60% before inclusion * PaO2/FiO2 ≤ 150 mmHg with FiO2 ≥ 60% and Spo2 between 92 and 96% after optimization by setting PEEP to 10 mmHg, sedation levels optimization and, if necessary, administration of neuromuscular blockers to ensure patient-ventilator synchrony, with VT ≤ 8 ml/kg PBW and Pplateau \< 30 cm H2O. Exclusion Criteria: * PP during the same ICU stay and before inclusion, ECMO before PP, arterio-venous ECMO * persistent PaO₂/FiO₂ ratios \<150 mm Hg, with FiO2 ≥ 60% on all arterial blood gases collected over a 24-hour period without this prompting study inclusion * Spine instability, intracranial pressure \> 20 mmHg, severe brain injury, hemodynamic instability deemed to contraindicate PP by the physician in charge * Home oxygen supplementation * Care limited to comfort measures only * Inclusion in another interventional study including mechanically ventilated patients, which intervention concerns PP and for which mortality à D28 or D30 is the main outcome studied. * Already included in PROSECO * Pregnancy, subject deprived of freedom, Person under conservartorship, no insurance * Refusal to participate expressed by the patient or his/her healthcare proxy or a close relative if present

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

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

Acute respiratory distress syndrome

How to take part

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

  1. The places running it

    1 site. 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

  • Hôpital Saint-Louis

    RECRUITING

    Paris, 75010, France

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