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临床试验/NCT01402934
NCT01402934已完成不适用

The Ability of Pulse Pressure Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients Undergoing Thoracic Surgery

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年5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
70
试验地点
1
主要终点
pulse pressure variation

研究概览

简要总结

The investigators hypothesized that pulse pressure variation (PPV) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction.

详细描述

Pulse pressure variation (PPV) is known to be a dynamic indicator to predict fluid responsiveness in mechanically ventilating patients. PPV is generated by cardiopulmonary interaction with respiratory cycles. In spontaneous breathing, the cardiopulmonary interaction may lead to PPV by inverted manner. In this study, the investigators will evaluate the ability of PPV to predict fluid responsiveness in spontaneously breathing patients. Before induction of anesthesia, radial artery cannulation is performed, and FloTrac/Vigileo (Edwards Lifesciences Corp., Irvine, USA) system is connected. And then, the investigators will measure baseline data including invasive blood pressure, pulse pressure, cardiac index, stroke volume variation in two different conditions: during tidal spontaneous breathing and during forced spontaneous breathing. All hemodynamic measurement will be repeated after infusion of fluid using 6mL/kg of hydroxyethyl starch solution (Voluven), and will be averaged over 3 minutes. Patients whose cardiac index increased by >15% to fluid infusion is defined as responders. The investigators will compare the hemodynamic parameters between responders and non-responders. To evaluate the ability to predict volume responsiveness, receiver operating characteristics curves of the PPV will be calculated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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
否

入选标准

  • •patients undergoing thoracic surgery

排除标准

  • •preoperative arrhythmia
  • •left ventricular ejection fraction <40%
  • •intra-cardiac valve disease
  • •intra-cardiac shunt
  • •pulmonary artery hypertension
  • •severe peripheral vascular obstructive disease
  • •decreased pulmonary function

研究组 & 干预措施

fluid infusion

Experimental

干预措施: Hydroxyethyl starch solution (Voluven) infusion (Procedure)

结局指标

主要结局

pulse pressure variation

时间窗: three respiratory cycles, an expected average of 30 seconds

次要结局

  • hemodynamic parameters(before and after fluid loading, 1 mimute)

研究者

申办方类型
Other

研究点 (1)

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