Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans
Condition: Body Temperature Changes
MeSH terms: Body Temperature Changes
Study type: Interventional

Summary: 
      This study compares three medical cooling devices for effectiveness of cooling the core of
      non-shivering subjects. This relates to common protocols to cool patients experiencing
      myocardial infarctions or stokes.
    

Detailed description: 
      Body core and brain cooling by 1-3°C has been used as an adjunct in treatment of stroke and
      myocardial infarction (MI) patients. Body surface cooling is simple and non-invasive however
      this process is difficult to implement effectively because skin cooling stimulates shivering
      heat production, a defense mechanism that protects the body core from cooling. It is
      sometimes necessary to pharmacologically inhibit shivering in order to cool the body from
      surface cooling strategies such as application of cold packs or cold water-perfused blankets
      or pads.

      Two commercial cooling units that are currently used are: 1) the Blanketrol III with standard
      Gel Pad (Gentherm Inc.); and 2) the Arctic Sun with hydrogel coated pads (Arctic Sun). A new
      cooling attachment system has been developed for the Blanketrol III. The new Kool Kit
      includes a head wrap, and a vest and lower body blanket. The effectiveness of the Kool Kit
      has not been quantified or compared to the current two systems mentioned above.

      Since shivering heat production attenuates core cooling, it must be eliminated in clinical or
      research settings where core cooling effectiveness is the main dependent variable. Previous
      studies from this laboratory (Laboratory for Exercise and Environmental Medicine) have used a
      human model for severe hypothermia which meperidine (Demerol) is infused to inhibit
      shivering. Under these conditions the primary core cooling capacity of a cooling system can
      be determined.

      The investigators intend to evaluate the Tco cooling rate, in hospital treatment conditions,
      [ambient temperature (Ta) = 22ºC] during surface cooling of non-shivering subjects with
      either: 1) Blanketrol with Gel Pads; 2) Blanketrol with Kool Kit; or 3) an Arctic Sun cooling
      system.

      The purpose is to compare the core cooling rates induced by three commercial surface cooling
      devices in non-shivering subjects. Because of the increased total surface area of the cooling
      pads and blankets, the investigators hypothesize that the Blanketrol with Kool Kit will have
      a greater rate of core cooling than the other two cooling systems tested.
    

Intervention name(s): Blanketrol cooling device and water-perfused blankets; Blanketrol and Kool Kit; Arctic Sun
Intervention type(s): Device; Device; Device
Intervention description(s): Blanketrol and water-perfused blankets; Blanketrol cooling device with water-perfused vest, hood and lower body blanket; Arctic Sun cooling device with gel cooling pads
Intervention model: Single Group Assignment
Intervention model description: Repeated measures design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: brain cooling; medical body cooling devices; Brain protection; hypoxia