- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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).
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Ramat Gan, Israël
- Werving
- Sheba Medical Center
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Contact:
- Amit Druyan, M.D
- E-mail: Amit.Druyan@sheba.health.gov.il
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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men wearing Semipermeable garment
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air permeable garment type BP2
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air permeable garment type BP3
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air permeable garment type MO
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air permeable garment type BP1
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The physiological burden of different CB Protective Garments
Tijdsspanne: 1 year
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Rectal temperature
Tijdsspanne: 1 year
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The rectal temperature will be mesured by rectal thermistore.
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1 year
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Skin temperature
Tijdsspanne: 1 year
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The skin temperature will be mesured by skin thermistores conected to 3 different sites (chest, leg and arm).
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1 year
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Heart rate
Tijdsspanne: 1 year
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Heart rate will be mesured by a polar watch.
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1 year
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Sweat rate
Tijdsspanne: 1 year
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The sweat rate will be calculated in each HTT from the subject's weight before and after the test and his water balance.
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1 year
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Amit Druyan, M.D, Medical Corps, Israel Defense Force
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 883-2009-CLIT
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Hittetolerantie
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Poitiers University HospitalVoltooidContinue niet-invasieve huidtemperatuur | Zero Heat Flux-methode | Slokdarm temperatuur | Arteriële temperatuur | Intracerebrale temperatuurFrankrijk
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University of WashingtonNational Institute of Environmental Health Sciences (NIEHS)Actief, niet wervendWarmte | Voorbereiding op noodsituaties | Extreme hitte | Heat Health | Extreme warmtegolven | Rampenbeheer | Rampenplanning | RampenVerenigde Staten