Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing (lifebeam)
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|ClinicalTrials.gov Identifier: NCT01789931|
Recruitment Status : Unknown
Verified May 2014 by Dr. Barliz Adato, Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : February 12, 2013
Last Update Posted : May 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Heat Illness||Device: "Lifebeam"||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
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.
- Heat tolerance test [ Time Frame: 1 year ]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 ]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 ]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 ]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 ]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 ]Evaluation by the optic sensor "Lifebeam" of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|