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HypothermiaNCT02685176

Head and Torso Rewarming Using a Human Model for Severe Hypothermia

A study testing Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.) and No heat in people with Hypothermia, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Clinical trial is being conducted to study the effectiveness of heat donation through head or torso in hypothermic rewarming efficacy using a human model for severe hypothermia. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Hypothermia
What is being tested?
Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.) and No heat
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteCanada
Study dates
Sep 2016to 30 Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adults, who answer "No" to all the questions on a Physical Activity Readiness Questionnaire (PAR-Q). Participants will also be interviewed to determine if they have any cardio-respiratory diseases, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure.

Who cannot join

  • A positive answer to any PAR-Q question, or any cardio-respiratory diseases, Renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Manitoba

    Winnipeg, Manitoba, R3T 2N2

Other trials in Canada

About this study

Official title: Efficacy of Head and Torso Rewarming by Using a Human Model for Severe Hypothermia

This Clinical trial is being conducted to study the effectiveness of heat donation through head or torso in hypothermic rewarming efficacy using a human model for severe hypothermia. The purpose of the study is to compare the core rewarming effectiveness of the same amount of heat donation through the head or torso in treatment of hypothermia using a human model for severe hypothermia. The information obtained from this study will give a better understanding of heat-transfer mechanisms. This might help in the ongoing research in hypothermia treatment.

Read the detailed description

Procedure:

Eight healthy, non-pregnant participants between 18 and 45 years old will be cooled in 8°C water, for 60 minutes or to a core temperature of 35ºC 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.

Conditions: The three treatment methods are as follows. A. Spontaneous rewarming (Shivering inhibition) In this control condition, Demerol will be infused through the arm or hand vein.

The first 1.5 mg/kg will be slowly injected in five equal doses (of 0.3 mg/kg) at 2 minute intervals during the last 10 minutes of cold water immersion. After removal from the water, further aliquots of 0.3 mg/kg (at minimum of 2-minute intervals) will be given only as necessary to inhibit any shivering that may develop, to a maximum cumulative dose of 3.2 mg/kg body weight.

After towel drying the subject will lie on a mattress under an insulated cover without any extra heating modality. Spontaneous rewarming will be the first condition for every subject, the results will be used to determine the dosage schedule for demerol in the active warming conditions below.

  1. Head warming:

Charcoal Heater applied to the Head (CH-H) - A charcoal heater (HEATPAC Personal Heater, Emergco Tech. Solutions, Vancouver) consists of a combustion chamber, a canister containing the charcoal fuel, and a branched heating duct that produces 250 W of heat. The canister is placed inside the combustion chamber and the charcoal fuel is ignited. Heated air is blown through the impermeable heating ducts by a fan within the charcoal heater above the combustion chamber. The combustion chamber will be placed on right side of the 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. The participant will be breathing ambient air (̴ 22˚C).

  1. Torso warming:

Charcoal Heater to the Torso (CH-T) - The same charcoal heater as above will be used. The combustion chamber will be placed on the subject's 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. Participant will be breathing ambient air at room temperature (~22˚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) until they wish to exit or core temperature reaches 37°C.

Research Design:

Each of the three experimental trials will be 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. Demerol will be administered by a licensed physician during the final 10 minutes of immersion to suppress shivering. Participants will then exit the water, be dried off and rewarmed with either head or torso warming techniques. After removal from the water, an extra dosage of demerol might be given to suppress shivering only if its necessary. The rewarming will be administered for 120 minutes or until the core temperature returns to normal values (̴36.5-37˚C). The order of warming methods will follow a modified balanced design with control being first and the two active warming conditions being balanced.

Conditions
Hypothermia
Being tested
Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.), No heat
Keywords
hypothermia, rewarming, non-shivering
Medical subject headings
Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)Device

    A heater (STK Heatpac) will be used in the active warming arms of the study.

  • No heatOther

    No active heating provided post cooling

Study groups in NCT02685176
Study groupRoleWhat they receive
No HeatExperimentalNo active heating will be provided post cooling
Receives: Other: No heat
HeadExperimentalCharcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the head following cooling
Receives: Device: Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)
TorsoExperimentalCharcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the torso following cooling
Receives: Device: Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rewarming Rate

    Rate of core temperature increase during rewarming

    Measured: 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion30 Sep 2018
  4. Study completion30 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02685176
Sponsor's protocol ID
B2015:101
Status last verified
Mar 2018
First submitted
12 Feb 2016
Last updated
1 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.) and No heat in people with Hypothermia, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rewarming Rate (time frame: 120 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.

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