Temperature Evaluation by MRI Thermometry During Cervical Cooling

NCT02431026 | Completed

• 1 other identifier: TEM-C
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

induced mild hypothermia; cervical cooling collar; mri brain thermometry; MRI thermometry; rate-of-cooling; Excel Cryo Cooling Collar

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Relationship between MRI temperature of brain and externally measured temperature

  45 minutes

Study Arms (2)

Cooling present

EXPERIMENTAL

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

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".

Interventions

Cooling pack activated Excel Cryo Cooling Collar DEVICE

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.

Cooling present

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• University of Vermont: lead
• Cryothermic Systems, Inc.: collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Study Officials

• Daniel Wolfson, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

US (1)