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Hypothermia Rewarming With Distal Limb Warming

Primary Purpose

Rewarming by Shivering Heat Production Only, Rewarming by Arm and Leg Immersion in Warm Water, Rewarming by Arm and Leg Exposure to Fluidotherapy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fluidotherapy warming device
Sponsored by
University of Manitoba
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rewarming by Shivering Heat Production Only focused on measuring rewarming, core cooling, afterdrop, hospital treatment, hypothermia

Eligibility Criteria

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

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

Core temperature rewarming rate
Esophageal temperature will be measured to determine the rate of core temperature increase during rewarming periods

Secondary Outcome Measures

Full Information

First Posted
April 4, 2013
Last Updated
December 2, 2015
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01827449
Brief Title
Hypothermia Rewarming With Distal Limb Warming
Official Title
Hypothermia Rewarming Effectiveness of Distal Limb Warming With Either Fluidotherapy or Warm Water Immersion
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (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 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
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: 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. Three ECG leads will be affixed to the skin. 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. 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.

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 Arm and Leg Immersion in Warm Water, Rewarming by Arm and Leg Exposure to Fluidotherapy
Keywords
rewarming, core cooling, afterdrop, 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
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Fluidotherapy warming device
Other Intervention Name(s)
Chattanooga Fluidotherapy model 115D
Intervention Description
Device uses airborne heated cellulose particles which are blown against the skin to provide convective warming.
Primary Outcome Measure Information:
Title
Core temperature rewarming rate
Description
Esophageal temperature will be measured to determine the rate of core temperature increase during rewarming periods
Time Frame
Sixty minutes post-cooling

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
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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Hypothermia Rewarming With Distal Limb Warming

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