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

Sponsor

Sheba Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01789931

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heat Illness	Device: "Lifebeam"	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: "Lifebeam" The "lifebeam" sensor will be attached to the participant's skin during the HTT.

Arm

Intervention/Treatment

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.

Device: "Lifebeam"

The "lifebeam" sensor will be attached to the participant's skin during the HTT.

Outcome Measures

Primary Outcome Measures

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

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.
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.
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).
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba medical center	Tel-Hashomer, Ramat- Gan		Israel

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator: Barliz Adato, MD, Heller institute, Sheba medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Barliz Adato, head investigator of Heller institute of physiology, Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT01789931

Other Study ID Numbers:

SHEBA-12-9435-BA-CTIL

First Posted:

Feb 12, 2013

Last Update Posted:

May 8, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Heat Stress Disorders

Study Results

No Results Posted as of May 8, 2014