The Affect of a Ventilated Helmet on Physiological Load

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Medical Corps, Israel Defense Force.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier:
NCT01595906
First received: March 22, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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 Intervention
Physiological Strain
Procedure: Ventilated Helmet

Study Type: Interventional
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

Further study details as provided by Medical Corps, Israel Defense Force:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
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)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   21 Years to 28 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595906

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

Locations
Israel
Heller insitute, Sheba hospital Not yet recruiting
Ramat-Gan, Israel
Contact: Amit Druyan, M.D       Amit.Druyan@sheba.health.gov.il   
Sponsors and Collaborators
Medical Corps, Israel Defense Force
Investigators
Principal Investigator: Amit Druyan, M.D IDF medical corps
  More Information

No publications provided

Responsible Party: Medical Corps, Israel Defense Force
ClinicalTrials.gov Identifier: NCT01595906     History of Changes
Other Study ID Numbers: 1037-2011-IDF-CTIL
Study First Received: March 22, 2012
Last Updated: May 14, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Medical Corps, Israel Defense Force:
Helmet
Heat Tolerance Test
ventilation System

ClinicalTrials.gov processed this record on July 24, 2014