HealthyTEM-CNCT02431026
Temperature Evaluation by MRI Thermometry During Cervical Cooling
A study testing Cooling pack activated Excel Cryo Cooling Collar in people with Healthy, run by University of Vermont at 1 site in United States.
Trial summary
The American Heart Association (AHA) recommends cooling (inducing mild hypothermia) patients who were resuscitated following cardiac arrest but who remained comatose. Induced mild hypothermia is now the standard of care for post-resuscitation patients in the intensive care unit (ICU) setting. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cooling pack activated Excel Cryo Cooling Collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Jul 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 18 years of age
- Understands the risks involved, as detailed in the informed consent
- No MRI risk factors
Who cannot join
- < 18 years of age \& > 60 years of age
- Pregnant
- Any known medical problems that limit activity or decrease blood flow: underactive thyroid (hypothyroidism),poor nutrition, stroke, severe arthritis, Parkinson's disease, dementia, significant mental illness besides clinical depression, spinal cord injuries, recent serious burn, disorders that affect sensation in the extremities (e.g., diabetic neuropathy)dehydration, and any condition that limits activity or restrains the normal flow of blood.
- Taking any medications (except seasonal allergy medication, over-the-counter NSAIDs, acetaminophen, or contraceptives)
- Oral medications that inhibit the body's ability to respond to cold: Antidepressants, antipsychotics/neuroleptics, including phenothiazines, beta blockers, clonidine, meperidine, sedative-hypnotics.
- History of cardiac condition in a family member younger than 40 years
- Inability to fit in the MRI scanner (BMI > 30 kg/m2)
- MRI risk factors (e.g., claustrophobia, heart condition, metal implants, etc), as detailed in the MRI safety questionnaire Heart rate, blood pressure, respiratory rate, or temperature outside of acceptable ranges.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
The American Heart Association (AHA) recommends cooling (inducing mild hypothermia) patients who were resuscitated following cardiac arrest but who remained comatose. Induced mild hypothermia is now the standard of care for post-resuscitation patients in the intensive care unit (ICU) setting. The use of cooling has recently moved to pre-hospital and emergency department (ED) application as more current studies show that early initiation of cooling significantly improves neurologic outcomes and survival rates instead of waiting until the patient arrives in the ICU to initiate cooling. In the pre-hospital setting chilled saline (4°C) and packing the body in ice have been the primary methods to initiate induced mild hypothermia The Excel Cryo Cooling System is a non-invasive cervical collar (C-collar) that provides cooling to the carotid arteries, the main blood supply to the brain, and allows for the rapid initiation of selective cerebral cooling. The investigators are planning to use MRI-thermometry to see how quickly the Excel Cryo Cooling Collar can drop brain temperature when applied by itself.
Healthy volunteers will be used for this study to provide important temperature data on the effectiveness of the Excel Cryo Cooling System. The investigators will be able to use the data from this project to further the current clinical research in induced mild hypothermia after cardiac arrest.
- Conditions
- Healthy
- Being tested
- Cooling pack activated Excel Cryo Cooling Collar
- Keywords
- induced mild hypothermia, cervical cooling collar, mri brain thermometry, MRI thermometry, rate-of-cooling, Excel Cryo Cooling Collar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling pack activated Excel Cryo Cooling CollarDevice
Cooling pack will be activated before insertion into collar. The first cooling pack will be replaced 20 minutes later with a new, activated cooling pack.
| Study group | Role | What they receive |
|---|---|---|
| Cooling present | Experimental | Cooling pack activated before start of MRI scan for the condition "cooling present". Receives: Device: Cooling pack activated Excel Cryo Cooling Collar |
| No cooling present | No intervention | Cooling pack will not be activated in the condition "no cooling present". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of cooling
MRI thermometry will be used to evaluate the rate of cooling
Measured: 45 minutes
Time to drop subject temperature 0.8-3.0°C
Temperatures changes will be evaluated using MRI thermometry
Measured: 45 minutes
Time to induced mild hypothermia threshold (34ºC)
Temperatures changes will be evaluated using MRI thermometry
Measured: 45 minutes
Differences and similarities of inducing mild hypothermia with the Excel Cryo Cooling Collar and normothermia
Temperatures changes will be evaluated using MRI thermometry
Measured: 45 minutes
Secondary outcomes (1)
Relationship between MRI temperature of brain and externally measured temperature
Skin surface temperature probe will be used to monitor any external temperature changes
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Cryothermic Systems, Inc.
- Responsible party
- Principal investigator, Daniel Wolfson, MD, University of Vermont
- Investigators
- Daniel Wolfson, MD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431026
- Sponsor's protocol ID
- TEM-C
- Acronym
- TEM-C
- Status last verified
- Sep 2016
- First submitted
- 27 Apr 2015
- Last updated
- 7 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Evaluation by MRI Thermometry During Cervical Cooling
- ClinicalTrials.gov ID
- NCT02431026
- Acronym / sponsor ID
- TEM-C / TEM-C
- Conditions
- Healthy
- Keywords
- induced mild hypothermia, cervical cooling collar, mri brain thermometry, MRI thermometry, rate-of-cooling, Excel Cryo Cooling Collar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Cryothermic Systems, Inc.
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Apr 2015 (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.
The American Heart Association (AHA) recommends cooling (inducing mild hypothermia) patients who were resuscitated following cardiac arrest but who remained comatose. Induced mild hypothermia is now the standard of care for post-resuscitation patients in the intensive care unit (ICU) setting. The use of cooling has recently moved to pre-hospital and emergency department (ED) application as more current studies show that early initiation of cooling significantly improves neurologic outcomes and survival rates instead of waiting until the patient arrives in the ICU to initiate cooling. In the pre-hospital setting chilled saline (4°C) and packing the body in ice have been the primary methods to initiate induced mild hypothermia The Excel Cryo Cooling System is a non-invasive cervical collar (C-collar) that provides cooling to the carotid arteries, the main blood supply to the brain, and allows for the rapid initiation of selective cerebral cooling. The investigators are planning to use MRI-thermometry to see how quickly the Excel Cryo Cooling Collar can drop brain temperature when applied by itself.
Healthy volunteers will be used for this study to provide important temperature data on the effectiveness of the Excel Cryo Cooling System. The investigators will be able to use the data from this project to further the current clinical research in induced mild hypothermia after cardiac arrest.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling present | Experimental | Device: Cooling pack activated Excel Cryo Cooling CollarCooling pack activated before start of MRI scan for the condition "cooling present". |
| No cooling present | No intervention | –Cooling pack will not be activated in the condition "no cooling present". |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- > 18 years of age
- Understands the risks involved, as detailed in the informed consent
- No MRI risk factors
Key exclusion criteria (8 listed)
- < 18 years of age \& > 60 years of age
- Pregnant
- Any known medical problems that limit activity or decrease blood flow: underactive thyroid (hypothyroidism),poor nutrition, stroke, severe arthritis, Parkinson's disease, dementia, significant mental illness besides clinical depression, spinal cord injuries, recent serious burn, disorders that affect sensation in the extremities (e.g., diabetic neuropathy)dehydration, and any condition that limits activity or restrains the normal flow of blood.
- Taking any medications (except seasonal allergy medication, over-the-counter NSAIDs, acetaminophen, or contraceptives)
- Oral medications that inhibit the body's ability to respond to cold: Antidepressants, antipsychotics/neuroleptics, including phenothiazines, beta blockers, clonidine, meperidine, sedative-hypnotics.
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 |
|---|---|---|
| Cooling pack activated Excel Cryo Cooling CollarCooling pack will be activated before insertion into collar. The first cooling pack will be replaced 20 minutes later with a new, activated cooling pack. | Device | Cooling present |
Primary outcome
Rate of cooling
Time frame: 45 minutes
MRI thermometry will be used to evaluate the rate of cooling
Time to drop subject temperature 0.8-3.0°C
Time frame: 45 minutes
Temperatures changes will be evaluated using MRI thermometry
Time to induced mild hypothermia threshold (34ºC)
Time frame: 45 minutes
Temperatures changes will be evaluated using MRI thermometry
Differences and similarities of inducing mild hypothermia with the Excel Cryo Cooling Collar and normothermia
Time frame: 45 minutes
Temperatures changes will be evaluated using MRI thermometry
1 secondary outcome
Relationship between MRI temperature of brain and externally measured temperature
Time frame: 45 minutes
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 7 Sep 2016.
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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.
Daniel Wolfson, MD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling pack activated Excel Cryo Cooling Collar in people with Healthy, run by University of Vermont at 1 site in United States.
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 8 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 7 Sep 2016. 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 United States. 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?
Rate of cooling (time frame: 45 minutes). The study lists 4 primary outcomes in all. 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 7 Sep 2016.