Body Temperature ChangesNCT04332224
Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans
A study testing Blanketrol cooling device and water-perfused blankets, Blanketrol and Kool Kit and Arctic Sun in people with Body Temperature Changes, run by University of Manitoba at 1 site in Canada.
Trial summary
This study compares three medical cooling devices for effectiveness of cooling the core of non-shivering subjects. This relates to common protocols to cool patients experiencing myocardial infarctions or stokes. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Changes
- What is being tested?
- Blanketrol cooling device and water-perfused blankets, Blanketrol and Kool Kit and Arctic Sun
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2020to 30 Apr 2022
- 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 Get Active Questionnaire (GAQ) and the "Medical Screening Questionnaire for Hypothermia Study'.
- Participants will also be interviewed to determine that they are free of any cardio- respiratory disease, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure.
- Also, the study will include women of child bearing potential willing to use highly effective birth control during the trial. All women of child bearing potential will complete the "Research participant information for female subjects" and undergo a pregnancy test at screening.
Who cannot join
- Anyone who gives a positive answer to any question in the GAQ or Medical Screening Questionnaire for Hypothermia Study, or who has any cardio-respiratory disease, renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure will be excluded.
- Subjects contraindicated for meperidine administration or who have any of the conditions listed below will also be excluded from the study.
- hypersensitivity to meperidine or any ingredients in the formulation
- known or suspected mechanical GI obstruction or any diseases/conditions that affect bowel transit
- suspected surgical abdomen (i.e. acute appendicitis or pancreatitis)
- severe CNS depression, head injury, increased cerebrospinal or intracranial pressure
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- convulsive disorder, delirium tremens
- hypothyroidism
- prostatic hypertrophy or urethral stricture
- sickle cell anemia
- Addison's disease
- Pheochromocitoma
- Known sensitivity or intolerance to the drug metoclopramide
- Use of medications that might interact negatively with meperidine. Examples should include MAO inhibitors at the time of screening or within 14 days of screening; CNS depressants; phenytoin; cimetidine; ritonavir; aclyclovir; skeletal muscle relaxants.
- pregnant women, breastfeeding women, and women planning on becoming pregnant
Trial locations and contacts
1 site in 1 country.
Canada1 site
211 Max Bell Centre, University of Manitoba
Winnipeg, Manitoba, R3T 2N2
About this study
This study compares three medical cooling devices for effectiveness of cooling the core of non-shivering subjects. This relates to common protocols to cool patients experiencing myocardial infarctions or stokes.
Read the detailed description
Body core and brain cooling by 1-3°C has been used as an adjunct in treatment of stroke and myocardial infarction (MI) patients. Body surface cooling is simple and non-invasive however this process is difficult to implement effectively because skin cooling stimulates shivering heat production, a defense mechanism that protects the body core from cooling. It is sometimes necessary to pharmacologically inhibit shivering in order to cool the body from surface cooling strategies such as application of cold packs or cold water-perfused blankets or pads.
Two commercial cooling units that are currently used are: 1) the Blanketrol III with standard Gel Pad (Gentherm Inc.); and 2) the Arctic Sun with hydrogel coated pads (Arctic Sun). A new cooling attachment system has been developed for the Blanketrol III. The new Kool Kit includes a head wrap, and a vest and lower body blanket. The effectiveness of the Kool Kit has not been quantified or compared to the current two systems mentioned above.
Since shivering heat production attenuates core cooling, it must be eliminated in clinical or research settings where core cooling effectiveness is the main dependent variable. Previous studies from this laboratory (Laboratory for Exercise and Environmental Medicine) have used a human model for severe hypothermia which meperidine (Demerol) is infused to inhibit shivering. Under these conditions the primary core cooling capacity of a cooling system can be determined.
The investigators intend to evaluate the Tco cooling rate, in hospital treatment conditions, [ambient temperature (Ta) = 22ºC] during surface cooling of non-shivering subjects with either: 1) Blanketrol with Gel Pads; 2) Blanketrol with Kool Kit; or 3) an Arctic Sun cooling system.
The purpose is to compare the core cooling rates induced by three commercial surface cooling devices in non-shivering subjects. Because of the increased total surface area of the cooling pads and blankets, the investigators hypothesize that the Blanketrol with Kool Kit will have a greater rate of core cooling than the other two cooling systems tested.
- Conditions
- Body Temperature Changes
- Being tested
- Blanketrol cooling device and water-perfused blankets, Blanketrol and Kool Kit, Arctic Sun
- Keywords
- brain cooling, medical body cooling devices, Brain protection, hypoxia
- Medical subject headings
- Body Temperature Changes, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blanketrol cooling device and water-perfused blanketsDevice
Blanketrol and water-perfused blankets
Blanketrol and Kool KitDevice
Blanketrol cooling device with water-perfused vest, hood and lower body blanket
Arctic SunDevice
Arctic Sun cooling device with gel cooling pads
| Study group | Role | What they receive |
|---|---|---|
| Non-shivering cooling group | Experimental | Cooling devices Receives: Device: Blanketrol cooling device and water-perfused blankets; Device: Blanketrol and Kool Kit; Device: Arctic Sun |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal temperature cooling rate
Rate at which esophageal temperature decreases
Measured: 120 minutes
Skin heat exchange
Body surface heat flux
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 posted2 Apr 2020
- Study start1 Mar 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures design
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332224
- Sponsor's protocol ID
- HS23118 (B2019:076)
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2020
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leclerc C, Talebian Nia M, Giesbrecht GG. Heat Transfer Capabilities of Surface Cooling Systems for Inducing Therapeutic Hypothermia. Ther Hypothermia Temp Manag. 2023 Sep;13(3):149-158. doi: 10.1089/ther.2023.0003. Epub 2023 Jun 5.
PubMed 37276032
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Blanketrol III and Arctic Sun in Cooling Non-shivering Humans
- ClinicalTrials.gov ID
- NCT04332224
- Acronym / sponsor ID
- HS23118 (B2019:076)
- Conditions
- Body Temperature Changes
- Keywords
- brain cooling, medical body cooling devices, Brain protection, hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 2 Apr 2020 (actual)
- 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 study compares three medical cooling devices for effectiveness of cooling the core of non-shivering subjects. This relates to common protocols to cool patients experiencing myocardial infarctions or stokes.
Detailed description
Body core and brain cooling by 1-3°C has been used as an adjunct in treatment of stroke and myocardial infarction (MI) patients. Body surface cooling is simple and non-invasive however this process is difficult to implement effectively because skin cooling stimulates shivering heat production, a defense mechanism that protects the body core from cooling. It is sometimes necessary to pharmacologically inhibit shivering in order to cool the body from surface cooling strategies such as application of cold packs or cold water-perfused blankets or pads.
Two commercial cooling units that are currently used are: 1) the Blanketrol III with standard Gel Pad (Gentherm Inc.); and 2) the Arctic Sun with hydrogel coated pads (Arctic Sun). A new cooling attachment system has been developed for the Blanketrol III. The new Kool Kit includes a head wrap, and a vest and lower body blanket. The effectiveness of the Kool Kit has not been quantified or compared to the current two systems mentioned above.
Since shivering heat production attenuates core cooling, it must be eliminated in clinical or research settings where core cooling effectiveness is the main dependent variable. Previous studies from this laboratory (Laboratory for Exercise and Environmental Medicine) have used a human model for severe hypothermia which meperidine (Demerol) is infused to inhibit shivering. Under these conditions the primary core cooling capacity of a cooling system can be determined.
The investigators intend to evaluate the Tco cooling rate, in hospital treatment conditions, [ambient temperature (Ta) = 22ºC] during surface cooling of non-shivering subjects with either: 1) Blanketrol with Gel Pads; 2) Blanketrol with Kool Kit; or 3) an Arctic Sun cooling system.
The purpose is to compare the core cooling rates induced by three commercial surface cooling devices in non-shivering subjects. Because of the increased total surface area of the cooling pads and blankets, the investigators hypothesize that the Blanketrol with Kool Kit will have a greater rate of core cooling than the other two cooling systems tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Non-shivering cooling group | Experimental | Device: Blanketrol cooling device and water-perfused blankets, Device: Blanketrol and Kool Kit, Device: Arctic SunCooling devices |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults, who answer "No" to all the questions on a Get Active Questionnaire (GAQ) and the "Medical Screening Questionnaire for Hypothermia Study'.
- Participants will also be interviewed to determine that they are free of any cardio- respiratory disease, Raynaud's Syndrome, or any other conditions that can be aggravated by cold exposure.
- Also, the study will include women of child bearing potential willing to use highly effective birth control during the trial. All women of child bearing potential will complete the "Research participant information for female subjects" and undergo a pregnancy test at screening.
Key exclusion criteria (15 listed)
- Anyone who gives a positive answer to any question in the GAQ or Medical Screening Questionnaire for Hypothermia Study, or who has any cardio-respiratory disease, renal dysfunction, Raynaud's Syndrome, past recreational drug use or any other conditions that can be aggravated by cold exposure will be excluded.
- Subjects contraindicated for meperidine administration or who have any of the conditions listed below will also be excluded from the study.
- hypersensitivity to meperidine or any ingredients in the formulation
- known or suspected mechanical GI obstruction or any diseases/conditions that affect bowel transit
- suspected surgical abdomen (i.e. acute appendicitis or pancreatitis)
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 |
|---|---|---|
| Blanketrol cooling device and water-perfused blanketsBlanketrol and water-perfused blankets | Device | Non-shivering cooling group |
| Blanketrol and Kool KitBlanketrol cooling device with water-perfused vest, hood and lower body blanket | Device | Non-shivering cooling group |
| Arctic SunArctic Sun cooling device with gel cooling pads | Device | Non-shivering cooling group |
Primary outcome
Esophageal temperature cooling rate
Time frame: 120 minutes
Rate at which esophageal temperature decreases
Skin heat exchange
Time frame: 120 minutes
Body surface heat flux
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 23 Jan 2023.
- Derived from this study: PubMed 37276032Leclerc C, Talebian Nia M, Giesbrecht GG. Heat Transfer Capabilities of Surface Cooling Systems for Inducing Therapeutic Hypothermia. Ther Hypothermia Temp Manag. 2023 Sep;13(3):149-158. doi: 10.1089/ther.2023.0003. Epub 2023 Jun 5.
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Enrolling by invitation
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blanketrol cooling device and water-perfused blankets, Blanketrol and Kool Kit and Arctic Sun in people with Body Temperature Changes, 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 3 inclusion and 15 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 23 Jan 2023. 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?
Esophageal temperature cooling rate (time frame: 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332224, which also lists 1 linked publication.
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 23 Jan 2023.