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临床试验/NCT04909645
NCT04909645Unknown不适用

A Comparison of Invasive and Non-invasive Measurement of Cardiac Index and Systemic Vascular Resistance in Living Donor Liver Transplantation

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
comparison of invasive and non-invasive measurement for cardiac index

研究概览

简要总结

Patients who are scheduled to receive living donor liver transplantation will be monitored with a radial and femoral arterial line. A pulmonary artery catheter will also be placed and central venous pressure, cardiac index, and cardiac output will also be monitored. Simultaneously, on the middle finger of the hand where the radial artery is monitored, Clearsight (Edwards Lifesciences, Irvine, CA), a finger cuff, is placed and noninvasive blood pressure, cardiac output, cardiac index are measured. Using the VitalDB program, the parameters measured with the invasive methods and the parameters obtained by the noninvasive method are compared.

详细描述

In many end stage liver disease patients, cardiac output (CO) is increased and systemic vascular resistance (SVR) is decreased. During liver transplantation it is common to see hemodynamic instability due to massive blood loss and clamping of the major vessels. As a result invasive monitoring via a pulmonary catheter is usually done to continuously monitor the CO and SVR. However, because of its invasiveness, complications such as pulmonary artery rupture and ventricular arrhythmia can occur.

Clearsight (Edwards Lifesciences, Irvine, CA) is a noninvasive technique using a finger cuff to measure not only blood pressure but also CO and cardiac index (CI).

There have been previous reports on the correlation of this noninvasive method in other patient populations but no studies have been done in liver recipients. Also no studies have been done comparing SVR.

Patients presenting for living donor liver transplantation are anesthetized according to the SNUH protocol. Right radial and femoral arterial lines are placed. A central catheter is placed in the right jugular vein and a pulmonary artery catheter (Swan-Ganz CCOmbo CCO/SvO2™; Edward Lifesciences LLC, Irvine, CA, USA) is placed. This is connected to the Vigilance™ hemodynamic monitor (Edwards Lifesciences) and central venous pressure (CVP), CO, CI are monitored and SVR is calculated by the following equation: SVR=(Mean arterial pressure-CVP)*80/CO. The Clearsight system is connected after the finger cuff is placed on the middle finger of the right hand. Blood pressure, CO, CI are measured and SVR is calculated.

The variables are compared in the following phases:

研究设计

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

  • routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent

排除标准

  • Patients with atrial fibrillation
  • Contraindications to pulmonary artery catheterization or needing attention to insertion of pulmonary artery catheter: right-sided endocarditis, tumors, right sided valvular disease, left bundle branch block
  • Patients with obstructive vascular disease in the upper extremities, anatomical deformities in the upper extremities, Raynaud syndrome, etc.

结局指标

主要结局

comparison of invasive and non-invasive measurement for cardiac index

时间窗: Phase 7(neohepatic3): 1 hour after reperfusion

cardiac index

comparison of invasive and non-invasive measurement for systemic vascular resistance

时间窗: Phase 7(neohepatic3): 1 hour after reperfusion

systemic vascular resistance measured by the following equation: SVR=(Mean arterial pressure-central venous pressure)\*80/cardiac output. Femoral MAP is used for the invasive measurement

次要结局

  • comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure(Phase 7(neohepatic3): 1 hour after reperfusion)

研究者

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

Seong Mi Yang

Clinical Assistant Professor

Seoul National University Hospital

研究点 (1)

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