Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01827449 |
| Other study ID # |
B2013:039 |
| Secondary ID |
NSERC 2011-6 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 4, 2013 |
| Last updated |
December 2, 2015 |
| Start date |
May 2013 |
| Est. completion date |
December 2013 |
Study information
| Verified date |
December 2015 |
| Source |
University of Manitoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Ethics Review Committee |
| Study type |
Interventional
|
Clinical Trial Summary
The study will compare the rewarming effectiveness of heat donation through the distal arms
and legs during rewarming of mildly hypothermic subjects. Warming will be accomplished
through either warm water immersion; and fluidotherapy. The investigators hypothesize that
fluidotherapy will be as, or more, effective compared to warm water immersion
Description:
Dr. Gordon Giesbrecht is studying/comparing the effectiveness of heat donation through the
distal arms and legs in rewarming a mildly hypothermic individual. Warming will be
accomplished through either warm water immersion; and fluidotherapy.
Procedure. Eight participants will be cooled in 8°C water 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.
Participants will be instrumented as follows:
1. About 12 heat flux disks (2 cm in diameter) will be taped to the skin on the arms,
legs, torso, head etc. to measure skin temperature and heat transfer from the skin.
2. Three ECG leads will be affixed to the skin.
3. Core temperature will be measured with a disposable esophageal thermocouple. A thin,
flexible tube will be inserted through the nose, to midway down the esophagus at the
level of the heart.
4. Oxygen consumption will be continuously measured with a metabolic cart. Participants
will be asked to wear a face mask which will collect the expired breath during the
cooling as well as the rewarming periods.
Conditions: The three treatment methods are as follows.
A. Spontaneous rewarming (Shivering only) - In this control condition, no external heat will
be provided and the participant will rewarm spontaneously with the heat produced from
shivering.
B. Warm water distal extremities immersion - Distal arms and legs will be immersed in warm
water at 45°C for rewarming.
C.Fluidotherapy distal extremities rewarming - Distal arms and legs will be immersed in
Fluidotherapy equipment for rewarming at 50°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).
Research Design: Each of the three experimental trials, 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. The participant
will then exit the water, be dried off and rewarmed with either lie inside a vapor barrier
within a hooded sleeping bag with the head inside the hood, or sitting with their distal
arms and legs immersed in either Fluidotherapy at 50°C or warm water at 45°C. The rewarming
will be administered for 60 minutes or until the core temperature returns to normal values
(̴36.5-37˚C). The order of warming methods will follow a balanced design.
