NCT01221012

Brief Summary

Current protective clothing of any kind, especially the nuclear-biological-chemical (NBC) protective garments, amplify thermal stress because of the inherent properties of the clothing material. High insulation coefficient and low water vapor permeability of the protective cloth limit the ability of sweat to readily evaporate, which consequently result with a significant elevation of body temperature and with excessive body fluid loss (because of inefficient sweating) that might result with significant dehydration. Combat soldiers require to perform intense physical activities under hostile environmental conditions, including in contaminated areas that need the use of protective garments. The ability to fulfill a mission derives from the soldier's professionalism and from his physiological limits. It is well established that wearing protective garments affect tolerance time (TT) and performance. To operate in contaminated areas suitable protective garments should be worn. The inherent characteristics of the current protective garments limit, however, the effective working periods with such an ensemble, which is further aggravated in hot climate. Thus, in an attempt to increase TT and enhance work effectiveness, improved protective garments, which result with a lessened heat-stress, are under different stages of development. The relative influence of air permeability properties, garment weight and garment construction on heat stress and physiological strain will be investigated. The results will be quantified in terms of body temperatures, heart rate, fluid balance, subjective sensation and the maximum wear time (if necessary extrapolated).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 29, 2012

Status Verified

March 1, 2012

Enrollment Period

3 years

First QC Date

October 13, 2010

Last Update Submit

March 28, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • The physiological burden of different CB Protective Garments

    The physiological burden of different CB Protective Garments will be mesured by a heat tolerance test (HTT). The subjects will undergo an HTT wearing different CB Protective Garments and the results which indicate physiological burden will be compared between the different garments.

    1 year

Secondary Outcomes (4)

  • Rectal temperature

    1 year

  • Skin temperature

    1 year

  • Heart rate

    1 year

  • Sweat rate

    1 year

Study Arms (5)

men wearing Semipermeable garment

air permeable garment type BP2

air permeable garment type BP3

air permeable garment type MO

air permeable garment type BP1

Eligibility Criteria

Age20 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Twelve young (20-30 yr) male subjects will voluntarily participate in this study

You may not qualify if:

  • heart conditions, blood pressure higher than 140/90 mmHg, known diabetes or any skin illness or lesions. Also be excluded are potential participants who were ill during the 2 weeks prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

RECRUITING

Study Officials

  • Amit Druyan, M.D

    Medical Corps, Israel Defense Force

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 14, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

March 29, 2012

Record last verified: 2012-03

Locations