Heat Stress and Physiological Strain of Permeable vs. Impermeable CB Protective Garment

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Medical Corps, Israel Defense Force
Sponsor:
Information provided by (Responsible Party):
amit druyan, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT01221012
First received: October 13, 2010
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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).


Condition
Heat Tolerance

Study Type: Observational
Study Design: Observational Model: Case Control

Resource links provided by NLM:


Further study details as provided by Medical Corps, Israel Defense Force:

Primary Outcome Measures:
  • The physiological burden of different CB Protective Garments [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Rectal temperature [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The rectal temperature will be mesured by rectal thermistore.

  • Skin temperature [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The skin temperature will be mesured by skin thermistores conected to 3 different sites (chest, leg and arm).

  • Heart rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Heart rate will be mesured by a polar watch.

  • Sweat rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The sweat rate will be calculated in each HTT from the subject's weight before and after the test and his water balance.


Estimated Enrollment: 12
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
men wearing Semipermeable garment
air permeable garment type BP2
air permeable garment type BP3
air permeable garment type MO
air permeable garment type BP1

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Twelve young (20-30 yr) male subjects will voluntarily participate in this study

Criteria

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
  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: NCT01221012

Contacts
Contact: Amit Druyan, M.D 972-03-7377180 Amit.Druyan@sheba.health.gov.il

Locations
Israel
Sheba medical center Recruiting
Ramat Gan, Israel
Contact: Amit Druyan, M.D       Amit.Druyan@sheba.health.gov.il   
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
Principal Investigator: Amit Druyan, M.D Medical Corps, Israel Defense Force
  More Information

No publications provided

Responsible Party: amit druyan, Principal Investigator, Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT01221012     History of Changes
Other Study ID Numbers: 883-2009-CLIT
Study First Received: October 13, 2010
Last Updated: March 28, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on August 28, 2014