跳至主要内容
临床试验/NCT03918603
NCT03918603终止不适用

Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
38
试验地点
1
主要终点
inflammation of biotrauma

研究概览

简要总结

Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS.

详细描述

the hypothesis is that ECMO, in addition to improving gas exchange, should limit the deleterious effects of mechanical ventilation (mechanical ventilation-induced lesions, VILI) by drastically reducing minute ventilation (volume reduction). current, Vt, reduction of respiratory rate, reduction of mechanical power, reduction of motor pressure or driving pressure), adapting the level of PEEP from the data collected by monitoring oesophageal pressure and systematically performing positioning sessions in the prone position. This ultra-protective strategy could thus promote the restoration of the integrity of the alveolo-capillary membrane and thus facilitate the healing of patients. In order to verify this concept and, if necessary, to propose a study whose objectives would be more clinical (mortality, ventilator-free days), we propose to carry out a study aimed at showing that this ultra-protective multimodal strategy reduces the lesions induced by mechanical ventilation compared to usual protective ventilatory management during the ECMO as proposed in the EOLIA study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •severe ARDS with a PaO2 / FiO2 ratio ≤ 70 mmHg (for at least 2h) measured at PEEP> 10 cmH2O and FiO2 = 1
  • •OR a severe ARDS with a PaO2 / FiO2> 70 ratio but <100 mmHg with a plateau pressure> 35 cmH2O and a pH <7.20

排除标准

  • •Patients with associated hemodynamic failure requiring veno-arterial ECMO
  • •Impossibility of setting up or contraindication to the placement of an esophageal tube
  • •Impossibility of realization of ventral decubitus
  • •Patient to receive corticosteroids during the first 48 hours following venous venous ECMO.
  • •Patients assisted by veno-venous ECMO for more than 24 hours.

研究组 & 干预措施

ultra-protective multimodal ventilation group

Experimental

Patient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48

干预措施: ventral décubitus (Other)

protective ventilation group

No Intervention

Patient will received usual care

结局指标

主要结局

inflammation of biotrauma

时间窗: 36months

Interleukine dosage in pg/mL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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