Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing (lifebeam)
CB (Chemical Biological)protective clothing provides a thermal resistance between the human body and its environment. CB protective clothing will be essential for combat soldiers in case of non conventional attacks. "Lifebeam" developed a new non invasive sensor for body core temperature detection. The research purpose is to evaluate the "Lifebeam" sensor during heat tolerance test while wearing CB protective clothing.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing|
- Heat tolerance test [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau.
- VO2 test [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.
- Skin temperature [ Time Frame: 1 year ] [ Designated as safety issue: No ]The volunteers will undergo heat tolerance test. Their skin temperature will be measured by skin thermistors and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
- Rectal temperature [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]The volunteers will undergo heat tolerance test. Their rectal temperature will be measured by rectal thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
- Heart rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
- blood circulation parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]Evaluation by the optic sensor "Lifebeam" of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Research arm
The participants will undergo an examination day in which they will complete VO2max test to evaluate their aerobic fitness. Afterwards they'll undergo 3 heat tolerance test (HTT) days: without CB protective clothing, with CB protective clothing, and with work clothes. During the tests, a "Lifebeam" sensor will be attached to their skin.
The "lifebeam" sensor will be attached to the participant's skin during the HTT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01789931
|Contact: Barliz Adato, MD||+972542662201||Barliz.Adato@sheba.health.gov.il|
|Sheba medical center||Not yet recruiting|
|Tel-Hashomer, Ramat- Gan, Israel|
|Contact: Barliz Adato, MD Barliz.Adato@sheba.health.gov.il|
|Principal Investigator:||Barliz Adato, MD||Heller institute, Sheba medical center|