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临床试验/NCT02977143
NCT02977143已完成不适用

Comparison of Positive End-expiratory Pressure-induced Increase in Central Venous Pressure and Stroke Volume Variation to Predict Fluid Responsiveness in Robot-assisted Laparoscopic Surgery: A Prospective Clinical Trial

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
fluid responsiveness

研究概览

简要总结

In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.

详细描述

In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. As a preload index, the predictability of central venous pressure, pulse pressure variation and stroke volume variations may be impaired due to the impaired hemodynamics that result from the effect of increased abdominal pressure and decreased venous return. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. Therefore, the authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.

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
20 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Adult patient undergoing robot-assisted laparoscopic radical prostatectomy or cystectomy.
  • •American Society of Anesthesiologist Physical Status Classification of 1, 2 or 3.

排除标准

  • •Medical history of arrhythmia or new-onset arrhythmia after anesthesia induction.
  • •Valvular or ischemic heart disease or left ventricular ejection fraction less than 40%.
  • •Any significant pulmonary disease or history of chronic obstructive pulmonary disease
  • •End-stage renal disease or preoperative creatinine > 1.4 mg/dl

研究组 & 干预措施

Fluid responsiveness test

Experimental

First, apply 10 cmH2O positive endexpiratory pressure (PEEP) and measure the increase in central venous pressure (CVP) as well as other preload indexes (central venous pressure, mean arterial pressure, stroke volume variation).

Second, measure the increase in cardiac index after administration of volulyte 300 ml.

If cardiac index increase more than 10%, fluid responsiveness is confirmed.

干预措施: Fluid loading of volulyte 300 ml (Procedure)

结局指标

主要结局

fluid responsiveness

时间窗: 5 minutes after administration of 300 ml volulyte

fluid responsiveness is determined when increase in cardiac index is more than 10%

次要结局

  • arterial carbon dioxide partial pressure (mmHg)(1 minutes after the start of skin closure)
  • central venous pressure(T4: 5 minutes after administration of volulyte 300 ml)
  • cardiac index(T4: 5 minutes after administration of volulyte 300 ml)
  • stroke volume variation(T4: 5 minutes after administration of volulyte 300 ml)
  • abdominal pressure(T4: 5 minutes after administration of volulyte 300 ml)
  • arterial oxygen partial pressure (mmHg)(1 minutes after the start of skin closure)
  • central venous pressure(5 minutes after the application of positive end-expiratory pressure of 10 cmH2O)
  • central venous pressure(one hour after the initiation of pneumoperitoneum)
  • cardiac index(one hour after the initiation of pneumoperitoneum)
  • stroke volume variation(one hour after the initiation of pneumoperitoneum)
  • abdominal pressure(one hour after the initiation of pneumoperitoneum)
  • cardiac index(5 minutes after the application of positive end-expiratory pressure of 10 cmH2O)
  • stroke volume variation(5 minutes after the application of positive end-expiratory pressure of 10 cmH2O)
  • abdominal pressure(5 minutes after the application of positive end-expiratory pressure of 10 cmH2O)
  • central venous pressure(5 minutes after removal of positive end-expiratory pressure)
  • cardiac index(5 minutes after removal of positive end-expiratory pressure)
  • stroke volume variation(5 minutes after removal of positive end-expiratory pressure)
  • abdominal pressure(5 minutes after removal of positive end-expiratory pressure)
  • arterial oxygen partial pressure (mmHg)(5 minutes after anesthesia induction)
  • arterial carbon dioxide partial pressure (mmHg)(5 minutes after anesthesia induction)
  • arterial oxygen partial pressure (mmHg)(1 minutes after the application of positive end-expiratory pressure of 10 cmH2O)
  • arterial carbon dioxide partial pressure (mmHg)(1 minutes after the application of positive end-expiratory pressure of 10 cmH2O)

研究者

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

Won Ho Kim, MD

Clinical Associate Professor

Seoul National University Hospital

研究点 (1)

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