Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-07-29
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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ECMO-physio group
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
P0.1 and delta Poeso integration into the decanulation decision
P0.1 and delta Poeso integration into the decanulation decision
ECMO-gazo group
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.
No interventions assigned to this group
Interventions
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P0.1 and delta Poeso integration into the decanulation decision
P0.1 and delta Poeso integration into the decanulation decision
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Patient with treatment limitation at the time of inclusion,
* Patient in the time frame of exclusion from another research protocol at the time of consent signing,
* Vulnerable patients: minor, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman.
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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François CREMIEUX
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Marseille
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ID-RCB
Identifier Type: OTHER
Identifier Source: secondary_id
RCAPHM23_0464
Identifier Type: -
Identifier Source: org_study_id
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