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Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospices Civiles de Lyon
Lyon, France
Assistance - Publique Hôpitaux de Marseille
Marseille, France
CHU de Nice
Nice, France
Assistance Publique - Hôpitaux de Paris
Paris, France
Start Date
July 29, 2025
Primary Completion Date
September 1, 2027
Completion Date
September 1, 2027
Last Updated
November 19, 2025
50
ESTIMATED participants
P0.1 and delta Poeso integration into the decanulation decision
OTHER
Lead Sponsor
Assistance Publique Hopitaux De Marseille
NCT06701669
NCT06790875
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07351435