Skip to main content
OpenTrials
Completed

NCT Number: NCT01603511

Effectiveness of Heat Donation Through the Head or Torso on Mild Hypothermic Rewarming

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • cardiopulmonary disease
  • any symptoms caused by cold exposure

Treatment and study plan

Rewarming modality

Device

A commercial charcoal heater will be applied to the torso or the head in two of the trials. The control trial involves shivering only.

Other names: Charcoal heater, STK Heatpac

Primary outcomes

  1. Rate of body core rewarming

    Time frame: 60 minutes

    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.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 23, 2012
Registry last updated
Apr 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.