Actively Recruiting
Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study
Led by Assistance Publique Hopitaux De Marseille · Updated on 2025-11-19
50
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the process of weaning patients with Acute Respiratory Distress Syndrome (ARDS) from veno-venous extracorporeal membrane oxygenation (vvECMO). This study focuses on assessing monitoring tools, specifically the pressure generated during a 100-millisecond expiratory occlusion (P0.1) and esophageal pressure variation (delta Poeso), to guide decisions regarding vvECMO weaning and decannulation. The study aims to improve understanding of how respiratory drive and effort affect mechanical ventilation duration in ARDS patients. Participants will undergo a final vvECMO weaning test with minimal ECMO support, including low ECMO flow and fresh gas flow, while on partial mechanical ventilation allowing spontaneous breathing. One group will have P0.1 and delta Poeso values monitored and used to guide decannulation decisions, while the other group will have these measurements monitored but blinded to the clinical team and not used in decision-making. This randomized, controlled design compares the impact of integrating these monitoring tools on weaning outcomes. During the study, participants will be closely monitored for respiratory parameters, mechanical ventilation duration, and clinical outcomes such as mortality and intensive care unit stay. Researchers will collect P0.1 and delta Poeso measurements from study inclusion until 48 hours after decannulation. Additional assessments include sedation duration, barotrauma incidence, prone positioning, corticosteroid use, and neuromyopathy. The primary outcome is the duration of mechanical ventilation following ECMO removal, with follow-up extending to 60 days after inclusion.
CONDITIONS
Brief 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
- 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 �3C= 0.5 bcg/kg/min for at least 3 hours
- Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
- Maximum inspiratory pressure �3C= 28 cm H2O, with a maximum driving pressure �3C= 15 cm H2O, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight
- ECMO membrane sweep flow �3C= 2 L/min
- Patient protected by social security
You will not qualify if you...
- 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 excluded due to participation in another research protocol at the time of consent
- Vulnerable patients including minors, adults under guardianship or curatorship, individuals deprived of liberty, and pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From inclusion until ECMO decannulation
Participants undergo the ultimate vvECMO weaning test with minimal ECMO support and mechanical ventilation allowing spontaneous breathing. P0.1 and delta Poeso values are monitored and integrated into the decannulation decision for the experimental group, while monitored blindly for the control group.
1 to multiple visits during weaning period
Duration - Up to 60 days after inclusion
Participants are monitored for up to 60 days after inclusion to assess mechanical ventilation duration, mortality, ICU and hospital stay, and other clinical outcomes.
Regular assessments during follow-up period
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
C
Christophe GUERVILLY, M.D.
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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