Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04332224
Study type Interventional
Source University of Manitoba
Contact
Status Completed
Phase N/A
Start date March 1, 2020
Completion date April 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT02948920 - Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery N/A
Completed NCT03368040 - Comparison Between Non-invasive Heat-flux and Invasive Core Temperature Monitoring
Completed NCT05140707 - Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of the Patients Undergoing Port Catheter Implantation N/A
Completed NCT02769468 - Effect of Probe Placement in Delivery Room on Temperature at the Admission of Premature Infants? N/A
Not yet recruiting NCT01863927 - The Effect of Ventilated Vest on Thermoregulation During Exercise in Hot Environment N/A
Completed NCT03815708 - Heat Stress in Wheelchair Sports
Completed NCT04463537 - The Effect of Auricle Position on Tympanic Thermometry N/A
Not yet recruiting NCT06389604 - Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience N/A
Completed NCT02518815 - Preoperative Warming Prevents Postoperative Hypothermia in Laparoscopic Gynecologic Surgery. A Randomized Control Trial N/A
Completed NCT02998463 - Facilitating Skin-to-Skin Contact In the Postnatal Period N/A
Recruiting NCT03068143 - Postoperative Temperature Monitoring In Brain Trauma N/A
Completed NCT04311268 - Follow Fever to Decide N/A
Not yet recruiting NCT06432491 - The Association Between Core Temperature and Health N/A
Recruiting NCT06230172 - Early Weaning From Incubator To Crib N/A
Completed NCT02502877 - Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia N/A
Not yet recruiting NCT05430997 - Hypothermia Risk Prediction Combined With Active Insulation Management in Geriatric Surgery N/A
Completed NCT05179681 - High-Flow Oxygen Preserve Intraoperative Body Temperature
Completed NCT01950026 - Temperature Skin Check After Cryotherapy Application Phase 3
Completed NCT04985617 - The Effects of Active Warming on Temperature on Core Body and Thermal Comfort N/A
Withdrawn NCT01011855 - Radiant Warmer Trial N/A