- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01221012
Heat Stress and Physiological Strain of Permeable vs. Impermeable CB Protective Garment
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).
연구 개요
상태
정황
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
-
Ramat Gan, 이스라엘
- 모병
- Sheba Medical Center
-
연락하다:
- Amit Druyan, M.D
- 이메일: Amit.Druyan@sheba.health.gov.il
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Twelve young (20-30 yr) male subjects will voluntarily participate in this study. The potential participants will be informed of the study's nature, purpose and medical risks. Their inclusion in the study requires the medical clearance by the study's physician (CRF) and after having filled out and sign an informed consent form
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
men wearing Semipermeable garment
|
|
air permeable garment type BP2
|
|
air permeable garment type BP3
|
|
air permeable garment type MO
|
|
air permeable garment type BP1
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The physiological burden of different CB Protective Garments
기간: 1 year
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rectal temperature
기간: 1 year
|
The rectal temperature will be mesured by rectal thermistore.
|
1 year
|
|
Skin temperature
기간: 1 year
|
The skin temperature will be mesured by skin thermistores conected to 3 different sites (chest, leg and arm).
|
1 year
|
|
Heart rate
기간: 1 year
|
Heart rate will be mesured by a polar watch.
|
1 year
|
|
Sweat rate
기간: 1 year
|
The sweat rate will be calculated in each HTT from the subject's weight before and after the test and his water balance.
|
1 year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Amit Druyan, M.D, Medical Corps, Israel Defense Force
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 883-2009-CLIT
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .