TEM-C: Temperature Evaluation by MRI Thermometry During Cervical Cooling

Sponsor

University of Vermont (Other)

Overall Status

Completed

CT.gov ID

NCT02431026

Collaborator

Cryothermic Systems, Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Cooling pack activated Excel Cryo Cooling Collar	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Temperature Evaluation by MRI Thermometry During Cervical Cooling

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cooling present Cooling pack activated before start of MRI scan for the condition "cooling present".	Device: Cooling pack activated Excel Cryo Cooling Collar 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.
No Intervention: No cooling present Cooling pack will not be activated in the condition "no cooling present".

Arm

Intervention/Treatment

Experimental: Cooling present

Cooling pack activated before start of MRI scan for the condition "cooling present".

Device: Cooling pack activated Excel Cryo Cooling Collar

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.

No Intervention: No cooling present

Cooling pack will not be activated in the condition "no cooling present".

Outcome Measures

Primary Outcome Measures

Rate of cooling [45 minutes]
MRI thermometry will be used to evaluate the rate of cooling
Time to drop subject temperature 0.8-3.0°C [45 minutes]
Temperatures changes will be evaluated using MRI thermometry
Time to induced mild hypothermia threshold (34ºC) [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 [45 minutes]
Temperatures changes will be evaluated using MRI thermometry

Secondary Outcome Measures

Relationship between MRI temperature of brain and externally measured temperature [45 minutes]
Skin surface temperature probe will be used to monitor any external temperature changes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years of age
Understands the risks involved, as detailed in the informed consent
No MRI risk factors

Exclusion Criteria:

< 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.