Status:
RECRUITING
Free for Weaning ECMO vs Respiratory Driven Study
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
ARDS (Acute Respiratory Distress Syndrome)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06876415
Start Date
July 29 2025
End Date
September 1 2027
Last Update
November 19 2025
Active Locations (4)
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1
Hospices Civiles de Lyon
Lyon, France
2
Assistance - Publique Hôpitaux de Marseille
Marseille, France, 13005
3
CHU de Nice
Nice, France
4
Assistance Publique - Hôpitaux de Paris
Paris, France