The Affect of a Ventilated Helmet on Physiological Load

The Affect of a Ventilated Helmet System on Human Physiological Load

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 Overview

• Status: Unknown
• Conditions: Physiological Strain
• Intervention / Treatment: Procedure: Ventilated Helmet

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat-Gan, Israel
    • Heller insitute, Sheba hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The experiment subjects; The subjects will undergo: 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.; Three consecutive days including 3 scenarios: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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological strain	The physiological strain will be determined by body core temperature and heart rate of the subjects during a heat tolerance test(HTT).	9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rectal temperature	The Rectal temperature will be mesured by a rectal thermistore during each HTT	9 days
Skin temperature	The Skin temperature will be mesured by skin thermistores on 4 sites (chest, leg and arm and head).	9 days
Heart Rate	Heart rate will be monitored using a polar watch.	9 days
Sweat Rate	Sweat rate will be calculated from the patient's weight and his water balance	9 days

Collaborators and Investigators

• Sponsor: Medical Corps, Israel Defense Force
• Investigators: Principal Investigator: Amit Druyan, M.D, IDF medical corps

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): February 1, 2013

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Estimate): May 15, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Heat Tolerance Test; Helmet; ventilation System
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: 1037-2011-IDF-CTIL