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临床试验/NCT01082614
NCT01082614已完成不适用

Evaluation of the Use of Arterial Pulse Waveform Contour Analysis for Early Goal Directed Therapy in Patients Undergoing Major Abdominal Surgery

Loma Linda University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2009年8月最近更新:
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
46
试验地点
2
主要终点
Length of Postoperative Hospital Stay

研究概览

简要总结

This study evaluates whether using information from a special arterial blood pressure monitor to guide how much fluid is given during surgery changes how long a patient stays in the hospital after the surgery. There is scientific evidence from using similar information from different devices that this technique might allow us to do a better job giving fluids during surgery and that this may be associated with shorter hospital stay after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • All patients requiring elective or semi-elective major abdominal surgery will be assessed for eligibility.

排除标准

  • Age under 18 years old,
  • Coagulopathy,
  • Significant renal/hepatic dysfunction (creatine >50% or liver enzymes > 50% of normal values),
  • Congestive heart failure,
  • Cardiac arrhythmias producing irregular rhythms, and
  • Patient choice.

研究组 & 干预措施

Standard fluid management

No Intervention

standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team

Goal directed therapy

Experimental

Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis

干预措施: Vigileo (Device)

结局指标

主要结局

Length of Postoperative Hospital Stay

时间窗: within one month

time in days from end of surgery to hospital discharge

次要结局

  • Quality of Recovery Score on Postoperative Day 2(Postoperative day 2)
  • Quality of Recovery Score on Postoperative Day 4(Postoperative day 4)

研究者

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

Davinder Ramsingh, MD

MD

Loma Linda University

研究点 (2)

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