Free for Weaning ECMO vs Respiratory Driven Study

Официальное название

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

Обзор

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.

Вмешательства

• Другое P0.1 and delta Poeso integration into the decanulation decision
  P0.1 and delta Poeso integration into the decanulation decision

Первичные конечные точки

• Duration of mechanical ventilation from ECMO decannulation to weaning from mechanical ventilation [Срок оценки: 60 days after inclusion]
• P0.1 and delta Poeso measurements [Срок оценки: From inclusion to 48h after decanulation]

Вторичные конечные точки (12)

• Mortality rate in intensive care unit [Срок оценки: 60 days after inclusion]
• Mortality rate in hospital [Срок оценки: 60 days after inclusion]
• Intensive care unit stay duration from inclusion [Срок оценки: 60 days after inclusion]
• Hospital stay duration from inclusion [Срок оценки: 60 days after inclusion]
• Total number of days spent on ECMO from admission to intensive care unit discharge [Срок оценки: 60 days after inclusion]
• Total duration of mechanical ventilation [Срок оценки: 60 days after inclusion]
• Time between the start of mechanical ventilation and ECMO cannulation [Срок оценки: 60 days after inclusion]
• Number of ventilator-free days [Срок оценки: 60 days after inclusion]
• Number of patients decannulated and then re-initiated on vvECMO [Срок оценки: 60 days after inclusion]
• Number of patients requiring controlled ventilation for at least 24 hours after decannulation [Срок оценки: 60 days after inclusion]
• Number of days with continuous sedation with or without continuous paralysis after decannulation [Срок оценки: 60 days after inclusion]
• Incidence of barotrauma assessed by radiographs and clinical examination after decannulation [Срок оценки: 60 days after inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Франция · 4 центра

• Hospices Civiles de Lyon — Lyon
• Assistance - Publique Hôpitaux de Marseille — Marseille
• CHU de Nice — Nice
• Assistance Publique - Hôpitaux de Paris — Paris

Идентификаторы

NCT: NCT06876415 · RCAPHM23_0464 · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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