Clinical trial NCT06876415: Free for Weaning ECMO vs Respiratory Driven Study
Official title: Monitoring of Occlusion Pressure and Esophageal Pressure to Guide Weaning From Venovenous ECMO in ARDS: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ARDS (Acute Respiratory Distress Syndrome)
Keywords: veno-venous ECMO
Decannulation
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Contraindication to the 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 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.

Primary outcomes:
measure: Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation
timeFrame: 60 days after inclusion
measure: P0.1 and delta Poeso measurements
timeFrame: From inclusion to 48h after decanulation
Secondary outcomes:
measure: Mortality rate in intensive care unit
timeFrame: 60 days after inclusion
measure: Mortality rate in hospital
timeFrame: 60 days after inclusion
measure: Intensive care unit stay duration from inclusion
timeFrame: 60 days after inclusion
measure: Hospital stay duration from inclusion
timeFrame: 60 days after inclusion
measure: Total number of days spent on ECMO from admission to intensive care unit discharge
timeFrame: 60 days after inclusion
measure: Total duration of mechanical ventilation
timeFrame: 60 days after inclusion
measure: Time between the start of mechanical ventilation and ECMO cannulation
timeFrame: 60 days after inclusion
measure: Number of ventilator-free days
timeFrame: 60 days after inclusion
measure: Number of patients decannulated and then re-initiated on vvECMO
timeFrame: 60 days after inclusion
measure: Number of patients requiring controlled ventilation for at least 24 hours after decannulation
timeFrame: 60 days after inclusion
measure: Number of days with continuous sedation with or without continuous paralysis after decannulation
timeFrame: 60 days after inclusion
measure: Incidence of barotrauma assessed by radiographs and clinical examination after decannulation
timeFrame: 60 days after inclusion
measure: Percentage of patients placed in prone positioning after decannulation
timeFrame: 60 days after inclusion
measure: Number of days on inhaled nitric oxide after decannulation
timeFrame: 60 days after inclusion
measure: Neuromyopathy on the day of decannulation
timeFrame: Day of decanulation
measure: Neuromyopathy on the day of weaning from mechanical ventilation
timeFrame: Day of weaning from mechanical ventilation
measure: Number of patients who received corticosteroid therapy
timeFrame: 60 days after inclusion
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance - Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique - Hôpitaux de Marseille
name: François CREMIEUX
role: STUDY_DIRECTOR
References: