3M(TM)SpotOn(TM) Temperature Monitoring System Thermometry Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 3M
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Body Temperature Difference in Degrees Celsius
研究概览
简要总结
Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.
详细描述
The core temperature of the body normally decreases in response to anesthesia. Deep tissue temperature can be used to estimate of body core temperature. Deep tissue temperature of the forehead will be measured using a new technology known as zero-heat-flux thermometry. The usual way to measure internal body temperature is within the nasal cavity (nasopharyngeal temperature). Nasopharyngeal and deep tissue temperatures will be measured simultaneously during surgery and compared for agreement. The hypothesis of this trial is that deep tissue temperature as measured by zero-heat-flux thermometry will agree with nasopharyngeal temperatures during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 17 years old
- •patients undergoing surgery during which core temperature is estimated
- •Willing to participate in trial
- •Able to provide consent
- •Adequate forehead surface area available for probe attachment
- •Urology, orthopedic, or general abdominal surgery
排除标准
- •Skin lesions at thermometer target site
- •Infectious disease
- •Bleeding disorder
- •Prone intraoperative positioning anticipated
- •Head and neck procedures
- •Cardiothoracic procedures
- •Tonsillectomy, cosmetic, or other brief surgical or nonsurgical procedures
结局指标
主要结局
Body Temperature Difference in Degrees Celsius
时间窗: Every 5 to 10 minutes, or as clinically indicated, for the duration of the surgery from the time of incision to the time of closure. The average duration of surgery was 57 minutes.
Body temperature difference as defined by Agreement (bias - Zero heat flux thermometry minus nasopharyngeal) between simultaneously-acquired nasopharyngeal and forehead deep tissue temperatures as assessed by Bland and Altman repeated measures technique.
次要结局
未报告次要终点