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临床试验/NCT03408197
NCT03408197已完成不适用

Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年11月19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
150
试验地点
1
主要终点
Core temperature after arriving to the post-anaesthesia care unit

研究概览

简要总结

In this study two warming methods will be compared in knee arthroplasty surgery. Barrier EasyWarm will be used in the study group and BairHugger upper body warming blanket in the control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. In the operating room warming will be continued with the same warming method. Primary end point is core temperature after arriving to post anaesthesia care unit. Hypothesis is that Barrier EasyWarm is not inferior to BairHugger in preventing inadvertent intraoperative hypothermia.

Few methods exist to measure the core temperature non-invasively. Zero-heat-flux technique is used in this study. During the study we will test the accuracy of the 3M BairHugger Temperature Monitoring System by placing two sensors onto the patients (n = 30) fore head. After that the accuracy of the Dräger Tcore is examined by comparing it with the 3M BairHugger Temperature Monitoring System. So the patients (n=30) have both these different core temperature monitoring systems on their foreheads. This observational monitoring study is performed from the patient number 80 until the end.

研究设计

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

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •BMI 25-40
  • •ASA class I-III
  • •elective primary unilateral kneearthroplasty
  • •spinal anaesthesia

排除标准

  • •ASA class > III
  • •unstable coronary artery disease
  • •revision surgery, bilateral arthroplasty
  • •general anaesthesia
  • •decreased mental status

研究组 & 干预措施

EasyWarm

Experimental

干预措施: EasyWarm (Device)

BairHugger

Active Comparator

干预措施: BairHugger (Device)

结局指标

主要结局

Core temperature after arriving to the post-anaesthesia care unit

时间窗: one hour

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Two Warming Methods in Knee Arthroplasty | 临床试验