NCT02431026

Temperature Evaluation by MRI Thermometry During Cervical Cooling

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2016-07-01
• First posted: 2015-04-30
• Last updated: 2016-09-07

Locations

1 site across 1 country: United States