Measuring Core Body Temperature Using a Novel Non-invasive Sensor
- Conditions
- Body Temperature Regulation
- Interventions
- Device: "Dräger" double sensor
- Registration Number
- NCT02691832
- Lead Sponsor
- Sheba Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 12
- Aged 18-40 years.
- Healthy civilian volunteers.
- Without known medical illness or medication use.
- History of heat injury.
- The existence or suspicion of existing cardiac or respiratory disease.
- Diabetes.
- Obesity.
- Infectious disease 3 days prior to the experiment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description research arm "Dräger" double sensor the trial contains one group which will undergo the described protocol three times: 1. connected to rectal thermistor and to the double sensor 2. connected to rectal thermistor, double sensor and cooling system of Icetron Technologies Ltd. 3. connected to rectal thermistor and to the double sensor integrated into a helmet.
- Primary Outcome Measures
Name Time Method Double sensor temperature 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 3 days for each participant rectal thermistor is the "gold standard" for core body temperature and will be measured continuously.
- Secondary Outcome Measures
Name Time Method skin temperature 3 days for each participant The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
heart rate 4 days for each participant heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Trial Locations
- Locations (1)
Sheba medical center
🇮🇱Tel-Hashomer, Ramat- Gan, Israel