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.
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.
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.
- 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).
- 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 group | Role | What they receive |
|---|---|---|
| No Heat | Experimental | No active heating will be provided post cooling Receives: Other: No heat |
| Head | Experimental | Charcoal 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.) |
| Torso | Experimental | Charcoal 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.
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.
- First posted18 Feb 2016 (estimated)
- Study startSep 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gordon G Giesbrecht, PhD, Principal investigator, University of Manitoba
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Head and Torso Rewarming by Using a Human Model for Severe Hypothermia
- ClinicalTrials.gov ID
- NCT02685176
- Acronym / sponsor ID
- B2015:101
- Conditions
- Hypothermia
- Keywords
- hypothermia, rewarming, non-shivering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 18 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Heat | Experimental | Other: No heatNo active heating will be provided post cooling |
| Head | Experimental | Device: Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the head following cooling |
| Torso | Experimental | Device: Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)Charcoal Heater (STK Heatpac, Emergco Tech Solutions, Vancouver) will be applied to the torso following cooling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)A heater (STK Heatpac) will be used in the active warming arms of the study. | Device | Head, Torso |
| No heatNo active heating provided post cooling | Other | No Heat |
Primary outcome
Rewarming Rate
Time frame: 120 minutes
Rate of core temperature increase during rewarming
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon G Giesbrecht, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
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.