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Head and Torso Rewarming Using a Human Model for Severe Hypothermia

Primary Purpose

Hypothermia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)
No heat
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring hypothermia, rewarming, non-shivering

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults, who answer "No" to all the questions on a Physical Activity Readiness Questionnaire (PAR-Q). Participants will also be interviewed to determine if they have any cardio-respiratory diseases, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure.

Exclusion Criteria:

  • A positive answer to any PAR-Q question, or any cardio-respiratory diseases, Renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure.

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

No Heat

Head

Torso

Arm Description

No active heating will be provided post cooling

Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the head following cooling

Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the torso following cooling

Outcomes

Primary Outcome Measures

Rewarming Rate
Rate of core temperature increase during rewarming

Secondary Outcome Measures

Full Information

First Posted
February 12, 2016
Last Updated
February 28, 2019
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02685176
Brief Title
Head and Torso Rewarming Using a Human Model for Severe Hypothermia
Official Title
Efficacy of Head and Torso Rewarming by Using a Human Model for Severe Hypothermia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Description
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. Solutions, Vancouver) consists of a combustion chamber, a canister containing the charcoal fuel, and a branched heating duct that produces 250 W of heat. The canister is placed inside the combustion chamber and the charcoal fuel is ignited. Heated air is blown through the impermeable heating ducts by a fan within the charcoal heater above the combustion chamber. The combustion chamber will be placed on right side of the face/head with ducts wrapping around the dorsum of the head, anteriorly over the forehead, nose, chin and the neck, not covering the eyes or the mouth. The participant will be breathing ambient air (̴ 22˚C). C. Torso warming: Charcoal Heater to the Torso (CH-T) - The same charcoal heater as above will be used. The combustion chamber will be placed on the subject's anterior chest with a towel in between. The flexible ducts will be applied to the areas of high heat transfer i.e. over the shoulders, neck, and then anteriorly under the axillae to cross over the lower anterior chest. Participant will be breathing ambient air at room temperature (~22˚C). Rewarming procedures will be administered either for a period of 60 minutes or until core temperature returns to normal values ( ̴ 36.5-37˚C). Following that, participants will be placed in a warm water bath (40-42˚C) until they wish to exit or core temperature reaches 37°C. Research Design: Each of the three experimental trials will be separated by at least 48 hours. On each of the three trials, participants will be immersed up to the level of the sternal notch in 8˚C for up to 60 minutes or until the core temperature falls to 35˚C. Demerol will be administered by a licensed physician during the final 10 minutes of immersion to suppress shivering. Participants will then exit the water, be dried off and rewarmed with either head or torso warming techniques. After removal from the water, an extra dosage of demerol might be given to suppress shivering only if its necessary. The rewarming will be administered for 120 minutes or until the core temperature returns to normal values (̴36.5-37˚C). The order of warming methods will follow a modified balanced design with control being first and the two active warming conditions being balanced.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
hypothermia, rewarming, non-shivering

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Heat
Arm Type
Experimental
Arm Description
No active heating will be provided post cooling
Arm Title
Head
Arm Type
Experimental
Arm Description
Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the head following cooling
Arm Title
Torso
Arm Type
Experimental
Arm Description
Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the torso following cooling
Intervention Type
Device
Intervention Name(s)
Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)
Intervention Description
A heater (STK Heatpac) will be used in the active warming arms of the study.
Intervention Type
Other
Intervention Name(s)
No heat
Intervention Description
No active heating provided post cooling
Primary Outcome Measure Information:
Title
Rewarming Rate
Description
Rate of core temperature increase during rewarming
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults, who answer "No" to all the questions on a Physical Activity Readiness Questionnaire (PAR-Q). Participants will also be interviewed to determine if they have any cardio-respiratory diseases, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure. Exclusion Criteria: A positive answer to any PAR-Q question, or any cardio-respiratory diseases, Renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon G Giesbrecht, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Head and Torso Rewarming Using a Human Model for Severe Hypothermia

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