Temperature Evaluation by MRI Thermometry During Cervical Cooling (TEM-C)

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Cooling pack activated Excel Cryo Cooling Collar

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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".

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between MRI temperature of brain and externally measured temperature	Skin surface temperature probe will be used to monitor any external temperature changes	45 minutes

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: Cryothermic Systems, Inc.
• Investigators: Principal Investigator: Daniel Wolfson, MD, University of Vermont

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 4, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: induced mild hypothermia; cervical cooling collar; mri brain thermometry; MRI thermometry; rate-of-cooling; Excel Cryo Cooling Collar
• Other Study ID Numbers: TEM-C