Clinical trial NCT01221012: Heat Stress and Physiological Strain of Permeable vs. Impermeable CB Protective Garment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heat Tolerance
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twelve young (20-30 yr) male subjects will voluntarily participate in this study

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).


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

Primary outcomes:
measure: The physiological burden of different CB Protective Garments
timeFrame: 1 year
Secondary outcomes:
measure: Rectal temperature
timeFrame: 1 year
measure: Skin temperature
timeFrame: 1 year
measure: Heart rate
timeFrame: 1 year
measure: Sweat rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Medical Corps, Israel Defense Force
name: Amit Druyan, M.D
role: PRINCIPAL_INVESTIGATOR
References: