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临床试验/NCT02306018
NCT02306018已完成不适用

Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
cardiac output

研究概览

简要总结

The investigators are trying to evaluate the agreement of cardiac output measurements taken using the specific thermistor-tipped arterial catheter ( the VolumeView ™ catheter) and the EV1000 ™ monitoring platform ( Edward lifesciences, Irvine, CA, USA) with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.

详细描述

In cirrhotic patient undergoing liver transplantation, there are an altered patterm of circulation, which is characterized by increased cardiac output, decreased peripheral vascular resistance, and reduced ventricular response to physiological, pharmacological, and surgical stress. Large blood loss and clamping/declamping of the inferior vena cava and portal vein during liver transplantation surgery can affect intravascular volume status, which in turn can lead to hemodynamic instability. Therefore, reliable cardiac output monitoring is particularly useful in the cirrhotic patient undergoing liver transplant. Pulmonary artery thermodilution has been used as a standard method for cardiac output assessment for many years. Pulmonary artery catheter can cause rare but serious complications. And it has some limitations for continuously monitoring cardiac output during rapid hemodynamic changes.

Recently, several minimally invasive CO monitors have been developed. The pulse contour technique continuously estimates CO through mathematical analysis of the waveform of arterial pressure. However, previous studies evaluating the reliability of the pulse contour techniques indicated conflicting results in cirrhotic patients during liver transplantation. Most of studies were performed by analyzing from radial artery pressure waveform. Because of rapid changing of intravascular volume, using inotropics, the monitoring of femoral artery pressure has been recommended during liver transplantation.

A new pulse wave analysis system has developed and introduced into clinical practice that consists of a specific thermistor -tipped femoral arterial catheter ( the VolumeView™ catheter) and the EV1000™ monitoring platform ( Edward lifesciences, Irvine, CA, USA). To continuously assess CO based on the femoral arterial pressure curve signal and it uses transpulmonary thermodilution for calibration. We are trying to evaluate the agreement of cardiac output measurements taken using EV1000™ / VolumeView™ with measurements taken using continuous pulmonary artery thermodilution cardiac output monitoring during orthotopic liver transplantation.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects undergoing living donor liver transplantation during the study period subjects older than 20yrs who can give informed consent

排除标准

  • those who are confirmed moderate severe aortic regurgitation by echocardiography those with infection on cannulation site

结局指标

主要结局

cardiac output

时间窗: intraoperative

L/minute, 28 participants, EV1000 by femoral artery, Pulmonary artery thermodilution

次要结局

  • stroke volume variability(during surgery every 10 minute, event time for example, anhepatic, liver in, reperfusion, using inotropics, changing ventilator setting)
  • systemic vascular resistance(intraoperative)
  • stroke volume(intraoperative)
  • ejection fraction(intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gwak Mi Sook

professor

Samsung Medical Center

研究点 (1)

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