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Can gentler breathing machines save ARDS patients on ECMO?

NCT ID NCT03918603

Disease control Sponsor: Assistance Publique Hopitaux De Marseille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Oct 15, 2026 · Last updated Oct 16, 2026 · Updated 1 time

Summary

Researchers test whether ultra-protective mechanical ventilation, combined with ECMO and prone positioning, reduces lung injury and inflammation in people with severe ARDS. Participants receive either the ultra-protective strategy or standard protective ventilation. The trial measures inflammation markers to see if the gentler approach limits ventilator-induced damage.

What this could mean

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

Active substance
ultra-protective mechanical ventilation combined with ECMO and prone positioning
What this could lead to
If it works, this could point to gentler ventilation settings that protect the lungs of people with severe ARDS who need ECMO.
What could go wrong
The trial is small and early, so results may not hold in larger groups. ECMO and prone positioning carry serious risks, including bleeding and infection.

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

38 people

The number who actually took part.

Started

Jul 2019

Finished

Jun 2021

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 to 100 years

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: * severe ARDS with a PaO2 / FiO2 ratio ≤ 70 mmHg (for at least 2h) measured at PEEP\> 10 cmH2O and FiO2 = 1 * OR a severe ARDS with a PaO2 / FiO2\> 70 ratio but \<100 mmHg with a plateau pressure\> 35 cmH2O and a pH \<7.20 Exclusion Criteria: * Patients with associated hemodynamic failure requiring veno-arterial ECMO * Impossibility of setting up or contraindication to the placement of an esophageal tube * Impossibility of realization of ventral decubitus * Patient to receive corticosteroids during the first 48 hours following venous venous ECMO. * Patients assisted by veno-venous ECMO for more than 24 hours.

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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.

ARDS, human

Contacts and locations

Locations

  • Assistance Publique Hopitaux de Marseille

    Marseille, 13354, France

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