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Completed

NCT Number: NCT02431026

Temperature Evaluation by MRI Thermometry During Cervical Cooling

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Rate of cooling

    Time frame: 45 minutes

    MRI thermometry will be used to evaluate the rate of cooling

  2. Time to drop subject temperature 0.8-3.0°C

    Time frame: 45 minutes

    Temperatures changes will be evaluated using MRI thermometry

  3. Time to induced mild hypothermia threshold (34ºC)

    Time frame: 45 minutes

    Temperatures changes will be evaluated using MRI thermometry

  4. 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

Secondary outcomes

  1. Relationship between MRI temperature of brain and externally measured temperature

    Time frame: 45 minutes

    Skin surface temperature probe will be used to monitor any external temperature changes

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Cryothermic Systems, Inc.

Registry information

Acronym: TEM-C

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2015
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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