An interventional study of Blanketrol cooling device and water-perfused blankets and Blanketrol and Kool Kit in Body Temperature Changes, sponsored by University of Manitoba. Completed at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-23.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
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.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 68 interventional studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →University of Manitoba is the lead sponsor of 555 studies on the registry; 89 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cooling devices
Device: Blanketrol cooling device and water-perfused blankets · Device: Blanketrol and Kool Kit · Device: Arctic Sun
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
Esophageal temperature cooling rate
Rate at which esophageal temperature decreases
Time frame: 120 minutes
Skin heat exchange
Body surface heat flux
Time frame: 120 minutes
Ran from Mar 2020 to primary completion in Apr 2022, 25 months.
Of 44 non-industry interventional studies with no phase under Body Temperature Changes, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's 25 months is above that.
Counting every sponsor, half of 44 studies reached it within 5 months; a quarter within 3 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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