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Can tailored breathing support and early muscle relaxants boost survival in ARDS?

NCT ID NCT06849570

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests two strategies for people with moderate-to-severe acute respiratory distress syndrome (ARDS) who need a breathing machine. First, researchers compare a personalized approach to setting airway pressure based on how much lung is recruitable against standard low or high pressure settings. Second, they test whether giving muscle relaxants early, rather than only as a rescue, improves survival when patients are placed face down. The main goal is to see if these approaches reduce deaths within 28 days.

What this could mean

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

Active substance
Personalized ventilator settings (PEEP and tidal volume) and early use of neuromuscular blocking agents (muscle relaxants)
What this could lead to
If successful, this could lead to a more personalized approach to mechanical ventilation and muscle relaxant use, potentially improving survival in ARDS patients.
What could go wrong
The trial is large but still experimental. The optimal ventilator settings and timing of muscle relaxants are debated, and results may not apply to all patients. Risks include complications from muscle relaxants and ventilator-induced lung injury.

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 1,200 people

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

Started

Nov 2025

Expected to finish

Nov 2029

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: * Invasive mechanical ventilation within 96 hours of ICU admission and within 72 hours of tracheal intubation for first randomization and then within 72 hours of the first randomization for the second randomization * Patients meeting the Berlin ARDS definition criteria with hypoxemia characterized as * for first randomization: PaO2/FiO2 ≤150 mmHg on a PEEP ≥5 cmH2O with FiO2≥0.6 while VT is 6 ml/kg Predicted Body Weight (PBW) and adequate sedation level to adjust mechanical ventilation settings * for second randomization: PaO2/FiO2 ≤150 mmHg on optimized ventilatory settings according to the first randomization, confirmed by two Arterial blood gas (ABG) analyses separated by an interval time of 4 hours and observed within 72 hours of the first randomization * Informed consent signed: * by the patient * Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent by written as per L. 1111-6 * Or in a situation urgently and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent. * Health insurance coverage Exclusion Criteria: * Age \< 18 years * Known pregnancy or breastfeeding * Participation in another interventional studies as long as these studies do not interfere with the primary endpoint and the secondary safety objectives of PEPER, or being in the exclusion period at the end of a previous study. * Intracranial pressure \> 30 mm Hg or cerebral perfusion pressure \< 60 mmHg * Severe chronic respiratory disease requiring long-term O2 therapy or home mechanical ventilation (except Continuous positive arway pressure (CPAP)/ Bilevel positive airway pressure (BIPAP) used for sleep apnea syndrome) * Chronic interstitial lung disease * Continuous neuromuscular blockade infusion at enrolment * Previous hypersensitivity or anaphylactic reaction to any NMBA * Neuromuscular disease that may potentiate neuromuscular blockade or impair spontaneous ventilation: amyotrophic lateral sclerosis, Guillain-Barré syndrome, myasthenia gravis, upper spinal injury at level C5 or above * Patients on ECMO or any technique of extracorporeal CO2 removal * Sickle cell disease * Actual body weight \>1 kg/cm of height * Severe chronic liver disease defined as a Child-Pugh score of 12-15 * Pneumothorax at randomization * Expected duration of mechanical ventilation \<48 hours * Simplified acute physiology score SAPS II score \>75 at the time of enrolment or suffering from a disease with an estimated survival time of less than two months * Decision to withhold life-sustaining treatment * Patients deprived of freedom or under legal authority * Unstable spine fracture

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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 (ARDS) Intensive care units (ICUS)

How to take part

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

  1. The places running it

    29 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

  • APHM CHU Nord

    RECRUITING

    Marseille, France

  • CH Aix

    RECRUITING

    Aix-en-Provence, France

  • CH Fleyriat

    RECRUITING

    Bourg-en-Bresse, France

  • CH de Bicêtre

    RECRUITING

    Le Kremlin-Bicêtre, France

  • CH du Mans

    RECRUITING

    Le Mans, France

  • CHI Fréjus Saint Raphaël

    RECRUITING

    Fréjus, France

  • CHU Grenoble

    RECRUITING

    Grenoble, France

  • CHU de Caen Normandie

    RECRUITING

    Caen, France

  • CHU de Nantes

    RECRUITING

    Nantes, France

  • CMC Foch

    RECRUITING

    Suresnes, France

  • Cavale Blanche

    RECRUITING

    Brest, France

  • Centre Hospitalier de Troyes

    RECRUITING

    Troyes, France

  • Croix Rousse

    RECRUITING

    Lyon, France

  • Groupement Hospitalier Sud

    RECRUITING

    Lyon, France

  • Hopital de l'Archet 1

    RECRUITING

    Nice, France

  • Hôpital André Mignot

    RECRUITING

    Versailles, France

  • Hôpital Bretonneau

    RECRUITING

    Tours, France

  • Hôpital Charles Nicolle

    RECRUITING

    Rouen, France

  • Hôpital Cochin AP-HP

    RECRUITING

    Paris, France

  • Hôpital Nord

    RECRUITING

    Saint-Etienne, France

  • Hôpital Pellegrin

    RECRUITING

    Bordeaux, France

  • Hôpital Raymond Poincaré AP-HP

    RECRUITING

    Garches, France

  • Hôpital Saint Louis

    RECRUITING

    Paris, France

  • Hôpital Sait Joseph Saint Luc

    RECRUITING

    Lyon, France

  • Hôpital de Brabois

    RECRUITING

    Nancy, France

  • Hôpital de Dieppe

    RECRUITING

    Dieppe, France

  • Hôpital de La Pitié Salpetrière AP-HP

    RECRUITING

    Paris, France

  • La Pitié Salpetriere hospital - AP-HP

    RECRUITING

    Paris, France

  • La Timone

    RECRUITING

    Marseille, France

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