RecruitingNot ApplicableNCT06876415

Free for Weaning ECMO vs Respiratory Driven Study

Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study


Sponsor

Assistance Publique Hopitaux De Marseille

Enrollment

50 participants

Start Date

Jul 29, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying P0.1 and delta Poeso integration into the decanulation decision for people with ards (acute respiratory distress syndrome). The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERP0.1 and delta Poeso integration into the decanulation decision

P0.1 and delta Poeso integration into the decanulation decision


Locations(4)

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

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NCT06876415


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