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临床试验/NCT01965574
NCT01965574已完成不适用

Evaluation of Performance Diagnosis of Hemodynamic Parameters of Preload Dependence in ARDS Patients During Prone Position

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence

研究概览

简要总结

Preload dependence assessment is difficult during prone position, and to date, no hemodynamic parameters have been validated to rationalize fluid loading in that position. This study aims to validate several hemodynamic parameters, using continuous cardiac output by pulse contour analysis and transpulmonary thermodilution.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • ARDS patient
  • mechanically ventilated in prone position
  • sedated and paralyzed
  • with continuous cardiac output monitoring by transpulmonary thermodilution and pulse contour analysis
  • fluid loading as indicated by attending physician

排除标准

  • Age below 18
  • no affiliation to social security
  • Vena cava obstruction
  • previous inclusion in protocol

结局指标

主要结局

Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence

时间窗: 1 minute after Trendelenburg position onset.

Preload dependence is assessed by the response in cardiac output to a 500 mL fluid loading, and is deemed positive if cardiac output increase by at least 15%

次要结局

  • Area under ROC curve of the respiratory variation in pulse pressure to detect preload dependence(1 minute after tidal volume increase to 8 ml/kg)
  • Area under ROC curve of the variation in continuous cardiac output during end-expiratory occlusion to detect preload dependence(15 seconds after the onset of end-expiratory occlusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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