Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06876415

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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