Using breathing‑drive measurements to decide when to stop veno‑venous ECMO

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial integrates two physiological measures — P0.1 (pressure generated during a 100‑ms occlusion) and esophageal pressure variation (delta Poeso) — into the clinical decision about when to remove vvECMO support. Eligible adult ARDS patients who meet standard weaning criteria (resolved cause of ARDS, hemodynamic stability, spontaneous ventilation mode, specified ventilator limits, and low ECMO sweep flow) will have these measurements taken to guide decannulation timing. The approach uses an esophageal pressure balloon to quantify respiratory effort alongside a standardized ventilator occlusion test for P0.1. The main aim is to determine whether using these objective respiratory‑drive markers changes timing of decannulation, duration of mechanical ventilation, and short‑term safety outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients aged 18 years or older Patient whose trusted person has given consent for participation in the study
* Patient on veno-venous ECMO with weaning criteria, including:
* Resolution of the cause of ARDS
* Absence of hemodynamic instability, defined as norepinephrine dose ≤ 0.5 μg/kg/min for at least 3 hours
* Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
* Maximum inspiratory pressure ≤ 28 cm H2O, with a maximum driving pressure ≤ 15 cm H2O, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight (PBW)
* ECMO membrane sweep flow ≤ 2 L/min
* Patient protected by social security

Exclusion Criteria:

* Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia),
* Patient with treatment limitation at the time of inclusion,
* Patient in the time frame of exclusion from another research protocol at the time of consent signing,
* Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.

Where it's running

• Hospices Civiles de Lyon
  Lyon, France Recruiting
• Assistance - Publique Hôpitaux de Marseille
  Marseille, France Recruiting
• CHU de Nice
  Nice, France Recruiting
• Assistance Publique - Hôpitaux de Paris
  Paris, France Recruiting

Study contacts

• Study coordinator: Sami HRAIECH, M.D., Ph.D
• Email: sami.hraiech@ap-hm.fr
• Phone: 04 91 96 58 35

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.