Effectiveness of Heat Donation Through the Head or Torso on Mild Hypothermic Rewarming
Primary Purpose
Rewarming by Shivering Heat Production Only, Rewarming by External Heat to the Torso, Rewarming by External Heat to the Head
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rewarming modality
Sponsored by
About this trial
This is an interventional treatment trial for Rewarming by Shivering Heat Production Only focused on measuring rewarming, core cooling, afterdrop, pre-hospital treatment, hypothermia
Eligibility Criteria
Inclusion Criteria:
- 18-45 yrs old, males or females, healthy
Exclusion Criteria:
- cardiopulmonary disease
- any symptoms caused by cold exposure
Sites / Locations
- University of Manitoba
Outcomes
Primary Outcome Measures
Rate of body core rewarming
Esophageal temperature will be used to determine the rate of core temperature rewarming during 60 minutes of rewarming via either shivering only, or external heat donated to the torso or the head.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01603511
Brief Title
Effectiveness of Heat Donation Through the Head or Torso on Mild Hypothermic Rewarming
Official Title
Effectiveness of Heat Donation Through the Head or Torso on Mild Hypothermic Rewarming
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will compare the rewarming effectiveness of heat donation through the head or the torso during rewarming of mildly hypothermic subjects. Warming will be accomplished through either forced-air warming or using a charcoal heater; both units are commonly used for warming. The investigators hypothesize that head warming will be as, or more, effective compared to
Detailed Description
Dr. Gordon Giesbrecht is studying/comparing the effectiveness of heat donation through the head or the torso in rewarming a mildly hypothermic individual. A rigid forced-air warming cover for the head or the torso will be used to rewarm the hypothermic individuals.
Subjects will be asked to participate in three experimental trials, separated by at least 48 hours. Each trial will last about 4 hours (1 hour for setup, 1 hour for cooling, and 2 hours for rewarming and removal of instrumentation).
On each of the three trials, subjects will undergo immersion to the level of the sternal notch in a tank of 8˚C water for up to 60 minutes. They will then exit the water, be dried off and lie in a hooded sleeping bag with the head inside the hood where one of the three warming procedures will be administered for 60 minutes or until core temperature returns to normal values ( ̴ 36.5-37˚C).
A. Spontaneous rewarming (Shivering Only) - In this control condition, no external heat will be provided and you will rewarm spontaneously with the heat produced from shivering.
B. Head Warming (Head): Either of these rewarming methods will be used:
Forced-Air Warming to the Head (FAW-H) - A modified rigid forced-air warming cover will be placed over your head. Warm air ( ̴43˚C) will blow into the cover through an inlet on top of the cover and will escape from the bottom of the cover. You will be breathing warm air (̴ 43˚C).
Charcoal Heater to the Head (CH-H) - A charcoal heater will be placed on right side of your 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. You will be breathing ambient air (̴ 22˚C).
C. Torso Warming - Either of these rewarming methods will be used:
Forced-Air Warming to the Torso (FAW-T) - A specially designed portable rigid forced-air cover (PORIFAC) will be placed over your torso and the upper thighs. Warm air (̴ 43˚C) will blow into the cover through an inlet above the abdomen and will escape from the bottom of the cover. Participant will be breathing ambient air (̴ 22˚C).
Charcoal Heater to the Torso (CH-T) - The charcoal heater will be placed on your 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. You will be breathing ambient air at room temperature (~22˚C).
After 60 minutes of warming, subjects will be placed in a warm water bath (40-42˚C) until they are comfortable and core temperature returns to normal values (̴ 36.5-37˚C).
Outcome measures include rate of core cooling, afterdrop amount, rate of rewarming, skin heat flux, oxygen consumption and shivering intensity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rewarming by Shivering Heat Production Only, Rewarming by External Heat to the Torso, Rewarming by External Heat to the Head
Keywords
rewarming, core cooling, afterdrop, pre-hospital treatment, hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Rewarming modality
Other Intervention Name(s)
Charcoal heater, STK Heatpac
Intervention Description
A commercial charcoal heater will be applied to the torso or the head in two of the trials. The control trial involves shivering only.
Primary Outcome Measure Information:
Title
Rate of body core rewarming
Description
Esophageal temperature will be used to determine the rate of core temperature rewarming during 60 minutes of rewarming via either shivering only, or external heat donated to the torso or the head.
Time Frame
60 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:
18-45 yrs old, males or females, healthy
Exclusion Criteria:
cardiopulmonary disease
any symptoms caused by cold exposure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon G Giesbrecht, Ph.D.
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
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Effectiveness of Heat Donation Through the Head or Torso on Mild Hypothermic Rewarming
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