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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01221012
Other study ID # 883-2009-CLIT
Secondary ID
Status Recruiting
Phase N/A
First received October 13, 2010
Last updated March 28, 2012
Start date December 2010
Est. completion date December 2014

Study information

Verified date March 2012
Source Medical Corps, Israel Defense Force
Contact Amit Druyan, M.D
Phone 972-03-7377180
Email Amit.Druyan@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 30 Years
Eligibility 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 Design

Observational Model: Case Control


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Sheba medical center Ramat Gan

Sponsors (1)

Lead Sponsor Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary The physiological burden of different CB Protective Garments 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 No
Secondary Rectal temperature The rectal temperature will be mesured by rectal thermistore. 1 year Yes
Secondary Skin temperature The skin temperature will be mesured by skin thermistores conected to 3 different sites (chest, leg and arm). 1 year No
Secondary Heart rate Heart rate will be mesured by a polar watch. 1 year Yes
Secondary Sweat rate 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 No
See also
  Status Clinical Trial Phase
Recruiting NCT01221038 - Standardization of a Heat Tolerance Test for Young Women as a Basis for Heat Tolerance Tests in Female Soldiers N/A