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临床试验/NCT02352324
NCT02352324已完成不适用

Continuous Cardiac Output Monitoring Using esCCO: a Validation vs. Transpulmonary Thermodilution in Off-pump Coronary Artery Bypass Grafting

Northern State Medical University2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Accuracy (between the method bias and angular bias) and precision (between the method standart deviation and radial limit of agreement) of esCCO cardiac output measurement

研究概览

简要总结

The main goal of our study is to assess the accuracy and reproducibility of continuous beat-to-beat cardiac output (CO) measurement using pulse wave transit time in patients undergoing off-pump coronary artery bypass grafting.

详细描述

Using appropriate statistical methods the cardiac index values obtained via pulse wave transit time with esCCO system will be compared with traditional transpulmonary thermodilution technique.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective isolated off-pump coronary arteries bypass grafting.
  • Age > 18 years and < 80 yrs.
  • Preoperative echocardiographic ejection fraction > 0.35

排除标准

  • Simultaneous operation (carotid endarterectomy, ventricular aneurysm resection, etc.).
  • Constant form of atrial fibrillation.
  • Severe valve dysfunction.
  • Peripheral vascular disease (including significant peripheral arteriopathy" which precludes the use of peripheral plethysmography).
  • The surgical requirement to harvest both radial arteries.
  • Intraaortic balloon pump.
  • Discontinuation Criteria:
  • Transfer to cardiopulmonary bypass (on-pump CABG).
  • The PEEP test will be discontinued before standard duration in patients with PEEP-induced profound MAP decrease below 50 mm Hg, bradycardia (< 50/min) or CIPCA < 1.9 l/min/m2 exceeding 1 minute.

结局指标

主要结局

Accuracy (between the method bias and angular bias) and precision (between the method standart deviation and radial limit of agreement) of esCCO cardiac output measurement

时间窗: Up to 24 hrs post surgery

Mean bias and standard deviation according to Bland-Altman analysis and angular bias and radial limit of agreement according to polar plot analysis for cardiac output assessed using pulse wave transit time in comparison with transpulmonary thermodilution

次要结局

  • Ability of augmented PEEP test (changes in cardiac output in response to an increase in PEEP) for predict the fluid responsiveness (changes in cardiac output in response to fluid load) in the early postoperative period(Immediate postoperatively)
  • Ability of mini fluid load test (changes in CO in response to fast injection of minimal fluid volume) to predict fluid responsiveness (changes in CO in response to injection of standard fluid volume) in the immediate postoperative period following OPCAB(Immediate postoperatively)

研究者

发起方
Northern State Medical University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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