Free for Weaning ECMO vs Respiratory Driven Study

Recruiting now · Not applicable

Conditions studied: ARDS (Acute Respiratory Distress Syndrome)

In brief

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.

Key facts

Study ID: NCT06876415
Run by: Assistance Publique Hopitaux De Marseille
People needed: 50
Starts: 2025-07-29
Expected to finish: 2027-09-01
Last updated by the study team: 2025-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Hospices Civiles de Lyon — Lyon, France (enrolling)
Assistance - Publique Hôpitaux de Marseille — Marseille, France (enrolling)
CHU de Nice — Nice, France (enrolling)
Assistance Publique - Hôpitaux de Paris — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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