Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing

Not Applicable

• Conditions: Heat Illness
• Interventions: Device: "Lifebeam"

• Registration Number: NCT01789931
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2013-02-10
• Study First Posted: 2013-02-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-07
• Last Update Posted: 2014-05-08
• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• age 21-30
• healthy
• after medical checkup
• after signing concent form

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Exclusion Criteria

• heart disease
• respiratory disease
• baseline bp above 140/90 mmHg
• sleep disorders
• diabetes
• anhydrosis
• skin disease
• acute illness in last 3 days prior to the examination

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Research arm	"Lifebeam"	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.

Primary Outcome Measures

Name	Time	Method
Heat tolerance test	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	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.

Secondary Outcome Measures

Name	Time	Method
blood circulation parameters	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
Rectal temperature	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.
Skin temperature	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.
Heart rate	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).

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Tel-Hashomer, Ramat- Gan, Israel