Free for Weaning ECMO vs Respiratory Driven Study

NCT06876415 | Recruiting

• 2 other identifiers: RCAPHM23_0464ID-RCB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

ARDS (Acute Respiratory Distress Syndrome)

Keywords

veno-venous ECMO; Decannulation

Outcome Measures

Primary Outcomes (2)

• Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation

  The weaning from mechanical ventilation is defined as the absence of mechanical ventilation for 48 consecutive hours.

  60 days after inclusion

• P0.1 and delta Poeso measurements

  P0.1 and delta Poeso values will be monitored and tracked at inclusion and then every 8 hours until decannulation, and up to 48 hours after decannulation. In the experimental group, these values will be incorporated into the criteria guiding the decannulation decision. In the control group, these values will be monitored and recorded by an investigator who is not involved in the decannulation decision. These values will not be included in the criteria guiding the decannulation decision.

  From inclusion to 48h after decanulation

Secondary Outcomes (17)

• Mortality rate in intensive care unit

  60 days after inclusion

• Mortality rate in hospital

  60 days after inclusion

• Intensive care unit stay duration from inclusion

  60 days after inclusion

• Hospital stay duration from inclusion

  60 days after inclusion

• Total number of days spent on ECMO from admission to intensive care unit discharge

  60 days after inclusion

Study Arms (2)

ECMO-physio group

EXPERIMENTAL

Patients undergo the ultimate vvECMO weaning test with minimal ECMO support (ECMO flow ≤ 3 L/min, fresh gas flow ≤ 1 L/min, FiO2 21%) and mechanical ventilation with partial support, allowing spontaneous ventilation. P0.1 and delta Poeso values will be monitored and integrated into the decannulation decision

Other: P0.1 and delta Poeso integration into the decanulation decision

ECMO-gazo group

NO INTERVENTION

Patients undergo the ultimate vvECMO weaning test with minimal ECMO support, similar to the experimental group. P0.1 and delta Poeso values will be monitored in a blinded manner by an independent investigator and will not be integrated into the decannulation decision.

Interventions

P0.1 and delta Poeso integration into the decanulation decision OTHER

P0.1 and delta Poeso integration into the decanulation decision

ECMO-physio group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 0.5 μg/kg/min for at least 3 hours
• Use of a ventilatory mode that allows spontaneous ventilation (VS-AI, BiPAP, or APRV)
• Maximum inspiratory pressure ≤ 28 cm H2O, with a maximum driving pressure ≤ 15 cm H2O, enabling tidal volumes between 4 and 8 ml/kg of predicted body weight (PBW)
• ECMO membrane sweep flow ≤ 2 L/min
• Patient protected by social security

You may not qualify if:

• Contraindication to the placement of an esophageal pressure balloon (e.g., esophageal varices, nasal trauma, uncontrolled coagulopathy, severe thrombocytopenia),
• Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (4)

Hospices Civiles de Lyon

Lyon, France

RECRUITING

Assistance - Publique Hôpitaux de Marseille

Marseille, 13005, France

RECRUITING

CHU de Nice

Nice, France

RECRUITING

Assistance Publique - Hôpitaux de Paris

Paris, France

RECRUITING

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• François CREMIEUX

  Assistance Publique - Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Sami HRAIECH, M.D., Ph.D

CONTACT

04 91 96 58 35; sami.hraiech@ap-hm.fr

Christophe GUERVILLY, M.D.

CONTACT

04 91 96 58 35; christophe.guervilly@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: P0.1 and delta Poeso values will be monitored in a blinded manner by an independent investigator and will not be integrated into the decannulation decision
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)