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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Barliz Adato, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01789931
First received: December 6, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 Intervention
Heat Illness
Device: "Lifebeam"

Study Type: Interventional
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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 10
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789931

Contacts
Contact: Barliz Adato, MD +972542662201 Barliz.Adato@sheba.health.gov.il

Locations
Israel
Sheba medical center Not yet recruiting
Tel-Hashomer, Ramat- Gan, Israel
Contact: Barliz Adato, MD       Barliz.Adato@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Barliz Adato, MD Heller institute, Sheba medical center
  More Information

No publications provided

Responsible Party: Dr. Barliz Adato, head investigator of Heller institute of physiology, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01789931     History of Changes
Other Study ID Numbers: SHEBA-12-9435-BA-CTIL
Study First Received: December 6, 2012
Last Updated: May 7, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on October 20, 2014