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

Heat Illness Clinical Trial

— lifebeam  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01789931
• Other study ID #: SHEBA-12-9435-BA-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 6, 2012
• Last updated: May 7, 2014
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: May 2014
• Source: Sheba Medical Center
• Contact: Barliz Adato, MD
• Phone: +972542662201
• Email: Barliz.Adato[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 30 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heat Illness

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer, Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heat tolerance test	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.	1 year	Yes
Primary	VO2 test	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.	1 year	Yes
Secondary	Skin temperature	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.	1 year	No
Secondary	Rectal temperature	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.	1 year	Yes
Secondary	Heart rate	During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).	1 year	Yes
Secondary	blood circulation parameters	Evaluation by the optic sensor "Lifebeam" of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles	1 year	No