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The Affect of a Ventilated Helmet on Physiological Load

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ClinicalTrials.gov Identifier: NCT01595906
Recruitment Status : Unknown
Verified May 2012 by Medical Corps, Israel Defense Force.
Recruitment status was:  Not yet recruiting
First Posted : May 10, 2012
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Medical Corps, Israel Defense Force

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Physiological Strain Procedure: Ventilated Helmet Not Applicable

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Affect of a Ventilated Helmet System on Human Physiological Load
Study Start Date : September 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : February 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: The experiment subjects

The subjects will undergo:

  1. 6 acclimatization days carried out by a standard protocol including a daily 2 hour effort performed in a climatic chamber, during which the subjects walk on a treadmill at 5km/h on a 2% incline under heat conditions (40 deg. centigrade & 40% RH). Core (rectal) and skin temperatures and heart rate will be monitored continuously.

  2. Three consecutive days including 3 scenarios:

    1. Without a helmet b.With a helmet c.With a ventilated helmet During the experiment days the subjects will be exposed to the following protocol : A 5 minute sitting, performing cognitive tests on a computer for 15 min, 120 min walking on a treadmill at 5km/h on a 2% incline, at the end of the effort the same cognitive tests will be repeated for extra 15 min, 155 min in total.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Physiological strain [ Time Frame: 9 days ]
    The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test(HTT).


Secondary Outcome Measures :
  1. Rectal temperature [ Time Frame: 9 days ]
    The Rectal temperature will be mesured by a rectal thermistore during each HTT

  2. Skin temperature [ Time Frame: 9 days ]
    The Skin temperature will be mesured by skin thermistores on 4 sites (chest, leg and arm and head).

  3. Heart Rate [ Time Frame: 9 days ]
    Heart rate will be monitored using a polar watch.

  4. Sweat Rate [ Time Frame: 9 days ]
    Sweat rate will be calculated from the patient's weight and his water balance


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 28 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy civilian volunteers
  • aged 21-28
  • without known medical illnesses or medication use

Exclusion Criteria:

  • the existence of or suspicion of existing cardiac or respiratory disease
  • hypertension
  • diabetes
  • any hormonal disease or any other chronic illness that may inhibit participation in the experiment
  • infectious disease 3 days prior to the experiment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595906


Contacts
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Contact: Amit Druyan, M.D Amit.Druyan@sheba.health.gov.il

Locations
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Israel
Heller insitute, Sheba hospital
Ramat-Gan, Israel
Contact: Amit Druyan, M.D       Amit.Druyan@sheba.health.gov.il   
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
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Principal Investigator: Amit Druyan, M.D IDF medical corps
More Information
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Responsible Party: Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT01595906    
Other Study ID Numbers: 1037-2011-IDF-CTIL
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Medical Corps, Israel Defense Force:
Helmet
Heat Tolerance Test
ventilation System
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries