Clinical Evaluation of TMS (Temperature Monitoring System) Performance
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Correlation between TMS and the esophageal/urinary temperature measurements
研究概览
简要总结
This Clinical study is preformed in order to estimate the performance of the TMS thermometer and to make a final tuning of the thermometer mathematical algorithm.
Body temperature of men, women and children will be measured using the TMS thermometer.
Each Patient will be measured both with the TMS thermometer and with an esophageal or urinal thermometer as a reference.
详细描述
Temperature measurement is vital during surgery. Accurate temperature reading can indicate patient's condition and alarm if something is wrong.
Nowadays, during surgeries temperature is measured mostly using an esophageal or a urinal thermometer, both of which are invasive, therefore they complicate the procedure and require time and activity of the medical stuff.
The TMS thermometer combines a noninvasive, biocompatible patch, which is attached to the body, and a receiving unit, which is placed near the body or the vital signs monitors and receives data from the patch. There is no connection between the body and the receiving unit. The measurement is based on a conductive sensor that measures the skin temperature and applies special algorithm in order to calculate the core body temperature.
The purpose of this clinical study is to evaluate the performance of the TMS thermometer and improve its algorithm by comparing its measurement to the esophageal or urinal temperature measurement
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men, women and children that are about to have surgery which requires temperature monitoring.
- •An informed consent was signed by the patient or his guardian.
排除标准
- •The medical staff decides that the patient can't participate.
结局指标
主要结局
Correlation between TMS and the esophageal/urinary temperature measurements
时间窗: The results of this study will be presented in 6 months from today (an average)
TMS will track patient's temperature during the operation concurrently with esophageal and/or urinary temperature sensor. Correlation will be calculated between both temperature measurement methods and tracking ability of the changes in patient's temperature during the operation will be compared.
次要结局
未报告次要终点