- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01221012
Heat Stress and Physiological Strain of Permeable vs. Impermeable CB Protective Garment
Current protective clothing of any kind, especially the nuclear-biological-chemical (NBC) protective garments, amplify thermal stress because of the inherent properties of the clothing material. High insulation coefficient and low water vapor permeability of the protective cloth limit the ability of sweat to readily evaporate, which consequently result with a significant elevation of body temperature and with excessive body fluid loss (because of inefficient sweating) that might result with significant dehydration.
Combat soldiers require to perform intense physical activities under hostile environmental conditions, including in contaminated areas that need the use of protective garments. The ability to fulfill a mission derives from the soldier's professionalism and from his physiological limits. It is well established that wearing protective garments affect tolerance time (TT) and performance.
To operate in contaminated areas suitable protective garments should be worn. The inherent characteristics of the current protective garments limit, however, the effective working periods with such an ensemble, which is further aggravated in hot climate. Thus, in an attempt to increase TT and enhance work effectiveness, improved protective garments, which result with a lessened heat-stress, are under different stages of development.
The relative influence of air permeability properties, garment weight and garment construction on heat stress and physiological strain will be investigated.
The results will be quantified in terms of body temperatures, heart rate, fluid balance, subjective sensation and the maximum wear time (if necessary extrapolated).
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Amit Druyan, M.D
- Phone Number: 972-03-7377180
- Email: Amit.Druyan@sheba.health.gov.il
Study Locations
-
-
-
Ramat Gan, Israel
- Recruiting
- Sheba Medical Center
-
Contact:
- Amit Druyan, M.D
- Email: Amit.Druyan@sheba.health.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Twelve young (20-30 yr) male subjects will voluntarily participate in this study. The potential participants will be informed of the study's nature, purpose and medical risks. Their inclusion in the study requires the medical clearance by the study's physician (CRF) and after having filled out and sign an informed consent form
Exclusion Criteria:
- heart conditions, blood pressure higher than 140/90 mmHg, known diabetes or any skin illness or lesions. Also be excluded are potential participants who were ill during the 2 weeks prior to the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
men wearing Semipermeable garment
|
air permeable garment type BP2
|
air permeable garment type BP3
|
air permeable garment type MO
|
air permeable garment type BP1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The physiological burden of different CB Protective Garments
Time Frame: 1 year
|
The physiological burden of different CB Protective Garments will be mesured by a heat tolerance test (HTT). The subjects will undergo an HTT wearing different CB Protective Garments and the results which indicate physiological burden will be compared between the different garments. |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rectal temperature
Time Frame: 1 year
|
The rectal temperature will be mesured by rectal thermistore.
|
1 year
|
Skin temperature
Time Frame: 1 year
|
The skin temperature will be mesured by skin thermistores conected to 3 different sites (chest, leg and arm).
|
1 year
|
Heart rate
Time Frame: 1 year
|
Heart rate will be mesured by a polar watch.
|
1 year
|
Sweat rate
Time Frame: 1 year
|
The sweat rate will be calculated in each HTT from the subject's weight before and after the test and his water balance.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amit Druyan, M.D, Medical Corps, Israel Defense Force
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 883-2009-CLIT
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