A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air
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
- Time Weighted Average Core Temperature
研究概览
简要总结
Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia.
Secondary hypotheses include that:
- intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming
- final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body-mass index 20-36 kg/m2
- •Age 18-75 yrs
- •ASA Physical Status 1-3
- •Supine position (with or without lithotomy)
排除标准
- •Pre-operative fever
- •Serious skin lesions
- •And contraindication to either PerfecTemp or forced-air warming
研究组 & 干预措施
Bair Hugger heated blanket
Patients will be warmed during surgery with the Bair Hugger heated blanket.
干预措施: heated blanket (Device)
LMA PerfecTemp system
Patients will be warmed during surgery with the PerfecTemp heated pad .
干预措施: heated pad (Device)
结局指标
主要结局
Time Weighted Average Core Temperature
时间窗: from tracheal intubation to 3 hours after or tracheal extubation
Time weighted average core temperature (esophogeal temperature) from tracheal intubation to 3 hours after or tracheal extubation
次要结局
- Proportion of Patients With Temperatures Above 36 Degree(at the end of surgery)
研究者
d sessler
Principal Investigator
The Cleveland Clinic