Measuring Core Body Temperature Using a Novel Non-invasive Sensor - a Follow up Study
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Double sensor temperature
研究概览
简要总结
The Double Sensor examined in this trial was developed by Dräger Company and is a novel non- invasive device for assessing core body temperature. In a preliminary research investigators have conducted the Double Sensor was found promising for potential use of physiological heat stress early detection. This follow-up experiment was designed to validate the data during high and changing body core temperatures and to examine the Double Sensor performance while integrated into a helmet as in intended application.
详细描述
12 healthy civilian volunteers will arrive to our lab and will undergo 4 experiment days: Recruitment day + VO2max test, 3 random days performing experiment protocol, dressed in uniforms: sitting in thermoneutral condition for one hour, afterwards they will walk on a treadmill in 5.5 km/h and 4% incline in hot chamber (40% celsius and 40% relative humidity) for 1.5 hours. Once connected to rectal thermistor and to the Double Sensor attached to the skin surface by sticker, once same as the day before with addition of cooling system of Icetron Technologies Ltd. worn on the wrist, and once connected to rectal thermistor and to the Double Sensor integrated into a helmet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 18-40 years.
- •Healthy civilian volunteers.
- •Without known medical illness or medication use.
排除标准
- •History of heat injury.
- •The existence or suspicion of existing cardiac or respiratory disease.
- •Diabetes.
- •Infectious disease 3 days prior to the experiment.
研究组 & 干预措施
research arm
the trial contains one group which will undergo the described protocol three times:
- connected to rectal thermistor and to the double sensor
- connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd.
- connected to rectal thermistor and to the double sensor integrated into a helmet.
干预措施: "Dräger" double sensor (Device)
结局指标
主要结局
Double sensor temperature
时间窗: 3 days for each participant
the Double Sensor will be attached to the forehead by sticker or integrated into a helmet. Double sensor temperature will be monitored continuously.
rectal temperature
时间窗: 3 days for each participant
rectal thermistor is the "gold standard" for core body temperature and will be measured continuously.
次要结局
- skin temperature(3 days for each participant)
- heart rate(4 days for each participant)