Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.
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
干预措施: EasyWarm (Device)
BairHugger
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
