The Affect of a Ventilated Helmet on Physiological Load
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The use of infantry helmets under heavy heat stress conditions, during physical exertion, may hinder the body's ability to effectively dissipate heat from the head area, thereby damaging the soldier's function. Therefore head cooling may potentially enable a longer duration of activity until reaching fatigue. An improvement in function may also be possible.The purpose of this research is to determine the extent of the cognitive and physiological strain caused by wearing a helmet under exertional conditions while exposed to heavy heat stress and to evaluate the effect of a unique ventilation system connected to the helmet on strain reduction.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Affect of a Ventilated Helmet System on Human Physiological Load|
- Physiological strain [ Time Frame: 9 days ] [ Designated as safety issue: No ]The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test(HTT).
- Rectal temperature [ Time Frame: 9 days ] [ Designated as safety issue: Yes ]The Rectal temperature will be mesured by a rectal thermistore during each HTT
- Skin temperature [ Time Frame: 9 days ] [ Designated as safety issue: No ]The Skin temperature will be mesured by skin thermistores on 4 sites (chest, leg and arm and head).
- Heart Rate [ Time Frame: 9 days ] [ Designated as safety issue: Yes ]Heart rate will be monitored using a polar watch.
- Sweat Rate [ Time Frame: 9 days ] [ Designated as safety issue: No ]Sweat rate will be calculated from the patient's weight and his water balance
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: The experiment subjects
The subjects will undergo:
Procedure: Ventilated Helmet
The ventilation system is installed on the inner part of the helmet and connected to a bellows and an energy source placed on the vest worn by the soldier. The system's working principal is based on air perfusion with a small ventilator.
12 young, healthy civilian volunteers, aged 21-28 will participate in the study. Following a day of examinations and 6 days of acclimatization in a climatic chamber in accordance with a well accepted protocol, the subjects will undergo 3 days of experiment that will include exposure to hot environmental conditions with different helmet-wearing scenarios, while wearing uniform and a combat vest: (a) without a helmet (b) with a helmet (c) with a helmet connected to a ventilation system. All 3 scenarios will include a two hour effort (walking on a treadmill) in heavy heat stress in the climatic chamber at our institute (the Heller institute of medical research).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595906
|Contact: Amit Druyan, M.D||Amit.Druyan@sheba.health.gov.il|
|Heller insitute, Sheba hospital||Not yet recruiting|
|Contact: Amit Druyan, M.D Amit.Druyan@sheba.health.gov.il|
|Principal Investigator:||Amit Druyan, M.D||IDF medical corps|