RecruitingNot Applicable

Free for Weaning ECMO vs Respiratory Driven Study

France50 participantsStarted 2025-07-29

Plain-language summary

In its most severe form, Acute Respiratory Distress Syndrome (ARDS) may require the use of veno-venous ECMO (vvECMO). While the criteria for vvECMO indication, ECMO settings, and ventilator management are relatively well-defined after the publication of the EOLIA trial and subsequent national or international guidelines, few studies have assessed the criteria and methods for weaning from vvECMO. Besides, advances in the understanding of the pathophysiology of mechanical ventilation (MV) weaning process have led to the development of specific monitoring tools for this phase. Schematically, respiratory drive can be evaluated via the ventilator by measuring the pressure generated during a 100-millisecond expiratory occlusion (P0.1) and respiratory efforts through the measurement of esophageal pressure variation (delta Poeso). Recent retrospective studies conducted on COVID-19 ARDS patients supported by vvECMO suggest a longer duration of mechanical ventilation for patients whose weaning and decannulation process was "forced," i.e., performed under conditions of significant respiratory drive and effort. High values of P0.1 and delta Poeso were associated with prolonged MV duration. Self-inflicted lung injury (P-SILI) and elevated transpulmonary pressure related to these uncontrolled respiratory efforts likely explain the negative impact on MV duration. Therefore, this randomized study proposes to assess these monitoring tools, which are regularly used in clinical practice, to guide vvECMO weaning and decannulation decisions.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation

Timeframe: 60 days after inclusion

P0.1 and delta Poeso measurements

Timeframe: From inclusion to 48h after decanulation

Trial details

NCT IDNCT06876415

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Sami HRAIECH, M.D., Ph.D

04 91 96 58 35 sami.hraiech@ap-hm.fr

View on ClinicalTrials.gov More ARDS (Acute Respiratory Distress Syndrome) trials