Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01221012
Recruitment Status : Unknown
Verified March 2012 by amit druyan, Medical Corps, Israel Defense Force.
Recruitment status was:  Recruiting
First Posted : October 14, 2010
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
amit druyan, Medical Corps, Israel Defense Force

Tracking Information
First Submitted Date October 13, 2010
First Posted Date October 14, 2010
Last Update Posted Date March 29, 2012
Study Start Date December 2010
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2011)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01221012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 12, 2011)
  • Rectal temperature [ Time Frame: 1 year ]
    The rectal temperature will be mesured by rectal thermistore.
  • Skin temperature [ Time Frame: 1 year ]
    The skin temperature will be mesured by skin thermistores conected to 3 different sites (chest, leg and arm).
  • Heart rate [ Time Frame: 1 year ]
    Heart rate will be mesured by a polar watch.
  • 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Heat Stress and Physiological Strain of Permeable vs. Impermeable CB Protective Garment
Official Title Not Provided
Brief Summary

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).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Twelve young (20-30 yr) male subjects will voluntarily participate in this study
Condition Heat Tolerance
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 13, 2010)
12
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01221012
Other Study ID Numbers 883-2009-CLIT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party amit druyan, Medical Corps, Israel Defense Force
Study Sponsor Medical Corps, Israel Defense Force
Collaborators Not Provided
Investigators
Principal Investigator: Amit Druyan, M.D Medical Corps, Israel Defense Force
PRS Account Medical Corps, Israel Defense Force
Verification Date March 2012