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临床试验/NCT04613752
NCT04613752终止不适用

Evaluation and Follow up of Diaphragm Function in Acute Respiratory Distress Syndrome Patients With Veino-venous Extracorporeal Oxygenation Membrane

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
63
试验地点
2
主要终点
Diaphragm function

研究概览

简要总结

Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS).

Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. The present study endeavors to evaluate and follow up the prevalence, risk factors and prognosis of diaphragm dysfunction in patients with VV-ECMO.

详细描述

Use of veno-venous extracorporeal oxygenation membrane is a therapeutic option for the management of the most severe patients with acute respiratory distress syndrome (ARDS). It allows to provide a protective lung ventilation by reducing the level of airway pressures generated by the ventilator. The objective is to minimize the harmful effects of mechanical ventilation in the lungs and to provide adequate gases exchanges. This strategy requires a deep sedation to allow a perfect synchrony between the patient and the ventilator. Such a synchrony puts the respiratory muscles - in particular the diaphragm - completely at rest.

Given the prolonged duration of this strategy, the question of its impact on the occurrence on diaphragm dysfunction has been raised. Such a dysfunction has been associated with prolonged duration of mechanical ventilation and poor outcomes but its effect in patients with veno-venous extracorporeal oxygenation membrane has never been evaluated so far.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • age > 18 years
  • ARDS according to the Berlin definition
  • patient or next of kin agrees to participate
  • patient with health insurance

排除标准

  • pregnancy
  • Opposition to participate
  • Contra indications to the phrenic nerves stimulation technique (pace maker, pneumothorax)"

结局指标

主要结局

Diaphragm function

时间窗: until day 28

as defined by the pressure generating capacity of the diaphragm \< 11 cmH2O

次要结局

  • Duration of ECMO(until day 60)
  • Duration of invasive mechanical ventilation(until day 60)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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