Could 'lung rest' on ECMO save more lives in severe ARDS?
NCT ID NCT06814340
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether giving the lungs a near-complete rest (apneic ventilation) early after starting ECMO helps people with the most severe form of acute respiratory distress syndrome (ARDS). About 280 participants will be randomly assigned to either near-apneic ventilation or standard ultra-protective lung ventilation. The goal is to see if this approach reduces lung injury, shortens time on ECMO, and improves survival at 60 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion. 2. Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patient is unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow. 3. French Social security registration (except AME) Exclusion Criteria: 1. Age \< 18 2. Pregnancy or breastfeeding 3. Initiation of VV-ECMO \> 48 h (maximum tolerance : +2h) 4. Cardiac arrest with cumulated no flow time \&gt;10 minutes before ECMO (within 48 hours prior to inclusion) 5. Irreversible neurological pathology 6. End-stage chronic lung disease 7. Contraindications for high PEEP level: untreated pneumothorax, barotrauma 8. Irreversible ARDS with no hope for lung function recovery 9. Patient moribund on the day of randomization, SAPS II \&gt;90 10. Liver cirrhosis (Child B or C) 11. Lung transplantation 12. Burns on more than 20 % of the body surface 13. Participation in another interventional study with a similar primary endpoint (mortality, lung transplantation, or duration of ECMO) or being in the exclusion period at the end of a previous study 14. Individuals under guardianship, or permanently legally incompetent adults
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Avicenne Hospital
RECRUITINGBobigny, France
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Brabois Hospital - CHRU Nancy
RECRUITINGNancy, France
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CHU Orléans
RECRUITINGOrléans, France
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CHU Tours
RECRUITINGTours, France
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Croix-Rousse Hospital - HCL
RECRUITINGLyon, France
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Haut Levèque Hospital - CHU Bordeaux
RECRUITINGBordeaux, France
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Henri Mondor Hospital
RECRUITINGCréteil, France
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Mercy Hospital - CHR Metz
RECRUITINGMetz, France
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North Hospital - APHM
RECRUITINGMarseille, France
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Pitié-Salpêtrière Hospital
RECRUITINGParis, France
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Pontchaillou Hospital - CHU Rennes
RECRUITINGRennes, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Steroid dose showdown: can more dexamethasone save lives in respiratory failure?
- Breathing machine settings put to the test in severe lung injury
- The hidden breath: how a mismatch between patient and machine may shape ARDS recovery
- Scientists hunt for hidden subgroups in sudden respiratory failure
- AI plus ultrasound could catch heart and lung decline before it turns critical