"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"

Официальное название

"Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme" - CALMDOWN

Обзор

The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation). The study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ARDS) rescued by ECMO. Indeed, our hypothesis is that that early (near) apneic ventilation on venovenous ECMO for severe ARDS can enhance ventilator injury prevention and therefore reduce ECMO duration and mortality at Day 60.

Вмешательства

• Устройство ECMO + near apneic ventilation
  Near apneic ventilation will be use during the first 3 days of ECMO. Patients will be ventilated in BIPAP/APRV or pressure-controlled ventilation. PEEP will be set to maintain the same mean airway pressure obtained during the standardized ventilation period pre-randomization to prevent lung derecruitment (PEEP ≥15cmH2O). If BIPAP/APRV is used, an RR of 2-4/min will be set with high pressure set at 30cmH20 for 3 sec. If pressure-controlled ventilation is selected, a respiratory rate of two sigh b
• Устройство ECMO + ultra-protective lung ventilation
  Ultra-protective lung ventilation will be used up to the ECMO weaning. This group will receive ultra-protective lung ventilation with BIPAP/APRV or VCV mode setting a PEEP \>10 cmH2O, ΔP 14-15 cmH2O, RR 15-20/min, Vt 3-4ml/kg and lowest FiO2 to maintain SpO2\>92%. The use of prone positioning during ECMO will be left at the physician's discretion.

Первичные конечные точки

• Efficacy of the application of early apneic ventilation on four components : mortality status at D60, need for lung transplantation at D60, persisting ECMO at D60, number of days alive between randomization and day 60 without ECMO [Срок оценки: Day 0 to Day 60]

Вторичные конечные точки (12)

• Mortality [Срок оценки: From Day 1 to Day 60]
• Mortality [Срок оценки: From Day 1 to Day 90]
• Need for lung transplant [Срок оценки: From Day 1 to Day 60]
• Need for lung transplant [Срок оценки: From Day 1 to Day 90]
• Duration of ECMO support [Срок оценки: From Day 1 to Day 60]
• Duration of ECMO support [Срок оценки: From Day 1 to Day 90]
• Duration of invasive mechanical ventilation [Срок оценки: From Day 1 to Day 60]
• Duration of invasive mechanical ventilation [Срок оценки: From Day 1 to Day 90]
• Duration of Intensive Care Unit [Срок оценки: From Day 1 to Day 60]
• Duration of Intensive Care Unit [Срок оценки: From Day 1 to Day 90]
• Hospital length of stay [Срок оценки: From Day 1 to Day 60]
• Hospital length of stay [Срок оценки: From Day 1 to Day 90]

Критерии участия

Критерии включения

• Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.
• Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patient is unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow.
• French Social security registration (except AME)

Критерии исключения

• Age < 18
• Pregnancy or breastfeeding
• Initiation of VV-ECMO > 48 h (maximum tolerance : +2h)
• Cardiac arrest with cumulated no flow time \&amp;gt;10 minutes before ECMO (within 48 hours prior to inclusion)
• Irreversible neurological pathology
• End-stage chronic lung disease
• Contraindications for high PEEP level: untreated pneumothorax, barotrauma
• Irreversible ARDS with no hope for lung function recovery
• Patient moribund on the day of randomization, SAPS II \&amp;gt;90
• Liver cirrhosis (Child B or C)
• Lung transplantation
• Burns on more than 20 % of the body surface
• Participation in another interventional study with a similar primary endpoint (mortality, lung transplantation, or duration of ECMO) or being in the exclusion period at the end of a previous study
• Individuals under guardianship, or permanently legally incompetent adults

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

Открытое

Основная цель

Лечение

Центры проведения

Франция · 11 центров

• Avicenne Hospital — Bobigny
• Haut Levèque Hospital - CHU Bordeaux — Bordeaux
• Henri Mondor Hospital — Créteil
• Croix-Rousse Hospital - HCL — Lyon
• North Hospital - APHM — Marseille
• Mercy Hospital - CHR Metz — Metz
• Brabois Hospital - CHRU Nancy — Nancy
• CHU Orléans — Orléans
• … и ещё 3 центра

Идентификаторы

NCT: NCT06814340 · APHP230850

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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