Actively Recruiting
Free for Weaning ECMO vs Respiratory Driven Study
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-11-19
50
Participants Needed
4
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Free for Weaning ECMO vs Respiratory Driven Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older whose trusted person has given consent for participation
- Patient on veno-venous ECMO meeting weaning criteria including resolution of ARDS cause
- Absence of hemodynamic instability with norepinephrine dose ≤ 0.5 µg/kg/min for at least 3 hours
- Use of a ventilatory mode allowing spontaneous ventilation (VS-AI, BiPAP, or APRV)
- Maximum inspiratory pressure ≤ 28 cm H2O and driving pressure ≤ 15 cm H2O with tidal volumes between 4 and 8 ml/kg of predicted body weight
- ECMO membrane sweep flow ≤ 2 L/min
- Patient protected by social security
You will not qualify if you...
- Contraindications to 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 currently excluded from another research protocol at time of consent
- Vulnerable patients including minors, adults under guardianship or curatorship, patients deprived of liberty, pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Hospices Civiles de Lyon
Lyon, France
Actively Recruiting
2
Assistance - Publique Hôpitaux de Marseille
Marseille, France, 13005
Actively Recruiting
3
CHU de Nice
Nice, France
Actively Recruiting
4
Assistance Publique - Hôpitaux de Paris
Paris, France
Actively Recruiting
Research Team
S
Sami HRAIECH, M.D., Ph.D
CONTACT
C
Christophe GUERVILLY, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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