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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

December 6, 2012
May 7, 2014
December 2014
December 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01789931 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing
Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Heat Illness
Device: "Lifebeam"
The "lifebeam" sensor will be attached to the participant's skin during the HTT.
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.
Intervention: Device: "Lifebeam"
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
10
December 2016
December 2015   (final data collection date for primary outcome measure)

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
Male
21 Years to 30 Years
Yes
Contact: Barliz Adato, MD +972542662201 Barliz.Adato@sheba.health.gov.il
Israel
 
NCT01789931
SHEBA-12-9435-BA-CTIL
No
Dr. Barliz Adato, Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Barliz Adato, MD Heller institute, Sheba medical center
Sheba Medical Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP