Hypothermia Rewarming With Distal Limb Warming

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr.Gordon Giesbrecht, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01827449
First received: April 4, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hypothermia Rewarming Effectiveness of Distal Limb Warming With Either Fluidotherapy or Warm Water Immersion

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Core temperature rewarming rate [ Time Frame: Sixty minutes post-cooling ] [ Designated as safety issue: No ]
    Esophageal temperature will be measured to determine the rate of core temperature increase during rewarming periods


Estimated Enrollment: 8
Study Start Date: May 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • cardiopulmonary disease
  • any symptoms caused by cold exposure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827449

Contacts
Contact: Gordon G Giesbrecht, PhD 204 474-8646 giesbrec@cc.umanitoba.ca

Locations
Canada, Manitoba
University of Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Principal Investigator: Gordon G Giesbrecht, PhD         
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: Dr.Gordon Giesbrecht, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01827449     History of Changes
Other Study ID Numbers: B2013:039, NSERC 2011-6
Study First Received: April 4, 2013
Last Updated: April 4, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
rewarming
core cooling
afterdrop
hospital treatment
hypothermia

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014