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临床试验/NCT02438228
NCT02438228已完成不适用

Estimation of Cardiac Output by Nine Different Pulse Contour Algorithms Compared With Transpulmonary Thermodilution

University Hospital Schleswig-Holstein2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年11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
30
试验地点
2
主要终点
Accuracy of cardiac output in l/min by nine different pulse contour algorithms compared with transpulmonary thermodilution

研究概览

简要总结

The aim of the present study is to compare accuracy and precision of Cardiac Output (CO) by nine different pulse contour algorithms with transpulmonary thermodilution before and after cardiopulmonary bypass (CPB).

详细描述

After induction of anesthesia, a central venous catheter and a transpulmonary thermodilution catheter (Pulsion Medical Systems, Munich, Germany) are introduced in the right internal jugular vein and in the femoral artery, respectively. The thermodilution catheter is connected to a PiCCO2 monitor (Software version 1.3.0.8). Thereafter, placement of an esophageal doppler probe is performed and the probe is connected to a unique Monitoring System (Deltex Medical, Chichester, UK) with nine different pulse contour algorithms. Cardiac Output by esophageal doppler is used to calibrate the nine different pulse contour algorithms.

After induction of anesthesia and establishment of all monitoring devices, a passive leg raising maneouvre (PLR) is performed and hemodynamic variables including CO by transpulmonary thermodilution (COTPTD) and CO by nine different pulse contour algorithms (COX1-9) are recorded before, during and after PLR. Subsequently, measurements of COTPTD and COX1-9 are carried out every 10 minutes until the beginning of CPB. Fifteen minutes after weaning from cardiopulmonary bypass calibration of nine different pulse contour algorithms by esophageal doppler are performed again and measurements of CITPTD and CIPFX are restarted up to the end of the surgical Intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Patients > 18 years of age with a left ventricular ejection fraction ≥ 0.
  • Patients undergoing coronary artery bypass grafting.

排除标准

  • Patients <18 years of age and with a left ventricular ejection fraction ≤0.5 are not considered for the study.
  • Emergency procedures and patients with hemodynamic instability requiring continuous pharmacologic support, intracardiac shunts, severe aortic-, tricuspid- or mitral stenosis or insufficiency and mechanical circulatory support were also excluded.

结局指标

主要结局

Accuracy of cardiac output in l/min by nine different pulse contour algorithms compared with transpulmonary thermodilution

时间窗: After induction of anesthesia until the end of surgery

次要结局

未报告次要终点

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ole Broch, MD

MD

University Hospital Schleswig-Holstein

研究点 (2)

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