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临床试验/NCT03485833
NCT03485833Unknown不适用

End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness in Mechanically Ventilated Cardiac Surgical Patients

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
responders

研究概览

简要总结

The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.

详细描述

Patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. Patients are monitored by transesophageal echocardiography and FloTrac/Vigileo. Hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (EEO) test, after end-inspiratory occlusion (EIO) test, after passive legs raising test, and after fluid challenge respectively. Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cardiac surgical patients
  • hypotension after induction of anesthesia
  • required volume expansion by clinical judgement of the anesthesiologist

排除标准

  • younger than 18 years
  • severe valve regurgitation or systolic dysfunction of the right ventricle
  • contraindication of the transesophageal echocardiography examination
  • cardiac arrhythmia
  • left ventricular ejection fraction less than 30% before surgery

研究组 & 干预措施

EEO and EIO test

Experimental

velocity time integral of the aorta measured by transesophageal echocardiography during end expiratory and end inspiratory occlusion test to predict volume responsiveness.Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

干预措施: EEO and EIO test (Diagnostic Test)

结局指标

主要结局

responders

时间窗: within 1 minute after volume expansion

responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid

次要结局

  • nonresponders(within 1 minute after volume expansion)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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