Temperature Evaluation by MRI Thermometry During Cervical Cooling

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Cooling pack activated Excel Cryo Cooling Collar

• Registration Number: NCT02431026
• Lead Sponsor: University of Vermont

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-04-30
• Primary Completion: 2016-04
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-04
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cooling present	Cooling pack activated Excel Cryo Cooling Collar	Cooling pack activated before start of MRI scan for the condition "cooling present".

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States