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临床试验/NCT01883752
NCT01883752已完成不适用

Goal-Directed Fluid Management Based on Non- Invasive Monitoring of Pulse Oximeter-Derived Pleth Variability Index

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 334 人开始时间: 2011年7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
334
试验地点
1
主要终点
Duration of hospital stay

研究概览

简要总结

The purpose of this study is to evaluate whether goal directed fluid management using respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has potential to decrease postoperative complications and outcomes.

详细描述

The aim of this study is to test the hypothesis that monitoring and minimizing the respiratory variations in the pulse oximeter waveform amplitude by volume loading has potential to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery.

In this study the investigators will test the impact of hemodynamic optimization based on the respiratory variations in the plethysmographic waveform amplitude to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery. The primary outcome variable is the incidence of postoperative complications. Secondary outcome variables are the duration of hospital and ICU stays, postoperative mortality, and cost of 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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients (male or female)
  • •Over 18 years old undergoing non-cardiac surgery
  • •Weight > 40 kg, Body Mass Index < 40

排除标准

  • •Patients who do not consent
  • •Body Mass Index > 40

研究组 & 干预措施

Control

No Intervention

Baseline crystalloid infusion of 5 mL/kg/hr of body weight.

Goal-directed Therapy group

Experimental

Goal-direct therapy

干预措施: Goal-directed Therapy group (Procedure)

结局指标

主要结局

Duration of hospital stay

时间窗: Maximum 90 days after surgery

The length of stay in the hospital is defined as postoperative number of days in the hospital until discharge.

次要结局

未报告次要终点

研究者

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

Maxime Cannesson

Associate Professor

University of California, Irvine

研究点 (1)

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