Temperature Evaluation by MRI Thermometry During Cervical Cooling

NCT ID: NCT02431026

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cooling present

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

Group Type: EXPERIMENTAL

Cooling pack activated Excel Cryo Cooling Collar

Intervention Type: 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.

No cooling present

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cryothermic Systems, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Daniel Wolfson, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Wolfson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont Medical Center

Burlington, Vermont, United States

Countries

United States

Other Identifiers

TEM-C

Identifier Type: -

Identifier Source: org_study_id