Hypothermia Rewarming With Distal Limb Warming

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01827449
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : December 3, 2015
Information provided by (Responsible Party):
Dr.Gordon Giesbrecht, University of Manitoba

Brief 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

Condition or disease Intervention/treatment Phase
Rewarming by Shivering Heat Production Only Rewarming by Arm and Leg Immersion in Warm Water Rewarming by Arm and Leg Exposure to Fluidotherapy Device: Fluidotherapy warming device Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypothermia Rewarming Effectiveness of Distal Limb Warming With Either Fluidotherapy or Warm Water Immersion
Study Start Date : May 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Intervention Details:
  • Device: Fluidotherapy warming device
    Device uses airborne heated cellulose particles which are blown against the skin to provide convective warming.
    Other Name: Chattanooga Fluidotherapy model 115D

Primary Outcome Measures :
  1. Core temperature rewarming rate [ Time Frame: Sixty minutes post-cooling ]
    Esophageal temperature will be measured to determine the rate of core temperature increase during rewarming periods

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18-45 yrs old, males or females, healthy

Exclusion Criteria:

  • cardiopulmonary disease
  • any symptoms caused by cold exposure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01827449

Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba

Responsible Party: Dr.Gordon Giesbrecht, Professor, University of Manitoba Identifier: NCT01827449     History of Changes
Other Study ID Numbers: B2013:039
NSERC 2011-6 ( Other Grant/Funding Number: NSERC Discovery Grant )
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: December 2015

Keywords provided by Dr.Gordon Giesbrecht, University of Manitoba:
core cooling
hospital treatment

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms