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临床试验/NCT04139733
NCT04139733招募中不适用

Early Use of Prone Position in Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
The proportion of patients successfully weaned from VV-ECMO,

研究概览

简要总结

Venovenous extracorporeal membrane oxygenation (VV-ECMO) is widely used in the salvage treatment of critical acute respiratory distress syndrome (ARDS). However, reducing lung injury, accelerating lung recovery, shortening VV-ECMO support time, and decreasing complications during the treatment need further study. By changing the body position of ARDS patients, the prone position can increase the lung's dorsal ventilation and improve the lung's ventilation/blood flow ratio to improve oxygenation. Previous multicenter studies have proved that the prone position can significantly reduce the mortality of patients with moderate and severe ARDS. However, patients with severe ARDS rescue by VV-ECMO rarely combine with a prone position.On the one hand, with the support of ECMO, the patient's oxygenation will be significantly improved, and they will no longer need the assistance of a prone position. In addition, the ECMO cannula brings some challenges to implementing a prone position. Only a few cohort studies have reported that VV-ECMO combined with a prone position could improve the oxygenation index and respiratory system compliance during the late treatment period.

The initial reason for PP in ARDS patients was to alleviate severe hypoxemia, as it was an efficient means to improve oxygenation in most patients. However, some patients were categorized as non-responders in the PP regarding oxygenation, which caused VV-ECMO therapy to be initiated. Should we decide to perform PP after VV-ECMO therapy no longer? This study evaluates whether early use of PP during VV-ECMO would increase the proportion of patients successfully weaned from VV-ECMO support compared with supine positioning in severe ARDS patients who received PP before ECMO.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • met the diagnostic criteria of Berlin's definition for ARDS;
  • had undergone prone positing before VV-ECMO;
  • receiving VV-ECMO support

排除标准

  • spinal instability;
  • elevated intracranial pressure;
  • facial/neck trauma;
  • recent sternotomy;
  • large ventral surface burn;
  • multiple trauma with unstabilized fractures;
  • severe hemodynamic instability;
  • massive hemoptysis;
  • high risk of requiring CPR or defibrillation;

结局指标

主要结局

The proportion of patients successfully weaned from VV-ECMO,

时间窗: After patients enrolled 60 days

Weaning VV-ECMO more than 48 hours with stable oxygenation and no need to re-establish ECMO

次要结局

  • 60-day mortality(After patients enrolled 60 days)

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rui Wang

Attending doctors

Beijing Chao Yang Hospital

研究点 (1)

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