Clinical Trial: Head and Torso Rewarming Using a Human Model for Severe Hypothermia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of Head and Torso Rewarming by Using a Human Model for Severe Hypothermia

Brief Summary: This Clinical trial is being conducted to study the effectiveness of heat donation through head or torso in hypothermic rewarming efficacy using a human model for severe hypothermia. The purpose of the study is to compare the core rewarming effectiveness of the same amount of heat donation through the head or torso in treatment of hypothermia using a human model for severe hypothermia. The information obtained from this study will give a better understanding of heat-transfer mechanisms. This might help in the ongoing research in hypothermia treatment.

Detailed Summary:

Procedure:

Eight healthy, non-pregnant participants between 18 and 45 years old will be cooled in 8°C water, for 60 minutes or to a core temperature of 35ºC on three occasions and then warmed by each of three warming conditions.

The study will include following specific procedures:

Anthropometric data which includes age, weight, height, and measurements of skinfold thickness at four sites- biceps, triceps, subscapularis, and suprailiac will be collected. Participant's heart rate and electrocardiogram will be monitored continuously throughout the experiment.

Conditions: The three treatment methods are as follows. A. Spontaneous rewarming (Shivering inhibition) In this control condition, Demerol will be infused through the arm or hand vein.

The first 1.5 mg/kg will be slowly injected in five equal doses (of 0.3 mg/kg) at 2 minute intervals during the last 10 minutes of cold water immersion. After removal from the water, further aliquots of 0.3 mg/kg (at minimum of 2-minute intervals) will be given only as necessary to inhibit any shivering that may develop, to a maximum cumulative dose of 3.2 mg/kg body weight.

After towel drying the subject will lie on a mattress under an insulated cover without any extra heating modality. Spontaneous rewarming will be the first condition for every subject, the results will be used to determine the dosage schedule for demerol in the active warming conditions below.

B. Head warming:

Charcoal Heater applied to the Head (CH-H) - A charcoal heater (HEATPAC Personal Heater, Emergco Tech. Sol
Sponsor: University of Manitoba

Current Primary Outcome: Rewarming Rate [ Time Frame: 120 minutes ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Manitoba

Dates:
Date Received: February 12, 2016
Date Started: September 2016
Date Completion: April 2017
Last Updated: January 16, 2017
Last Verified: January 2017