- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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).
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Ramat Gan, Israel
- Rekrytering
- Sheba Medical Center
-
Kontakt:
- Amit Druyan, M.D
- E-post: Amit.Druyan@sheba.health.gov.il
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
men wearing Semipermeable garment
|
|
air permeable garment type BP2
|
|
air permeable garment type BP3
|
|
air permeable garment type MO
|
|
air permeable garment type BP1
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The physiological burden of different CB Protective Garments
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rectal temperature
Tidsram: 1 year
|
The rectal temperature will be mesured by rectal thermistore.
|
1 year
|
|
Skin temperature
Tidsram: 1 year
|
The skin temperature will be mesured by skin thermistores conected to 3 different sites (chest, leg and arm).
|
1 year
|
|
Heart rate
Tidsram: 1 year
|
Heart rate will be mesured by a polar watch.
|
1 year
|
|
Sweat rate
Tidsram: 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
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Amit Druyan, M.D, Medical Corps, Israel Defense Force
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 883-2009-CLIT
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .