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

Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study

This study will test whether measuring ventilator drive (P0.1) and esophageal pressure swings to guide decannulation helps adult ARDS patients on veno‑venous ECMO come off ECMO sooner and safely.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (Academic / other)
• Locations: 4 sites (Lyon and 3 other locations)
• Trial ID: NCT06876415 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with ARDS on veno‑venous ECMO who meet the listed weaning criteria (resolved ARDS cause, stable hemodynamics, spontaneous ventilation mode, acceptable inspiratory/driving pressures, and ECMO sweep ≤ 2 L/min) are ideal candidates.

Not a fit: Patients with contraindications to an esophageal pressure balloon, active treatment limitations, or who do not meet the weaning criteria are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this method could shorten time on ECMO and mechanical ventilation and reduce complications from prolonged support.

How similar studies have performed: Retrospective series in COVID‑19 ARDS have suggested relationships between respiratory‑drive markers and prolonged ventilation, but prospective randomized evidence of benefit from drive‑guided decannulation is currently limited.

Eligibility criteria

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 this trial is running

Lyon and 3 other locations

• 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

Conditions ARDS; veno-venous ECMO; Decannulation