The Affect of a Ventilated Helmet on Physiological Load

Physiological Strain Clinical Trial

Official title:

The Affect of a Ventilated Helmet System on Human Physiological Load

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01595906
• Other study ID #: 1037-2011-IDF-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 22, 2012
• Last updated: May 14, 2012
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2012
• Source: Medical Corps, Israel Defense Force
• Contact: Amit Druyan, M.D
• Email: Amit.Druyan[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: February 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 28 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physiological Strain

Intervention

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.

Locations

Country	Name	City	State
Israel	Heller insitute, Sheba hospital	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rectal temperature	The Rectal temperature will be mesured by a rectal thermistore during each HTT	9 days	Yes
Secondary	Skin temperature	The Skin temperature will be mesured by skin thermistores on 4 sites (chest, leg and arm and head).	9 days	No
Secondary	Heart Rate	Heart rate will be monitored using a polar watch.	9 days	Yes
Secondary	Sweat Rate	Sweat rate will be calculated from the patient's weight and his water balance	9 days	No