Clinical Resources

FDA-Cleared Indications for Use

The WElkins Temperature Management System and Cooling Headliner have passed rigorous third party testing to verify their electrical safety (per UL 60601-1 and IEC 60601-1-6), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993). The System has been cleared by the U.S. Food and Drug Administration (FDA) with the following indications for use:

The WElkins EMT/ICU Temperature Management System is a thermal regulating system, indicated for temperature reduction in patients where clinically indicated.

Select Studies & Guidelines

1. WElkins Pilot Study (J Neuro 2004)

Neurosurgeons at Illinois Neurological Institute examined the efficacy of a prototype WElkins cooling system to rapidly and selectively lower brain temperature in severe stroke or head injury patients, with the intent to maximize neuroprotection and minimize systemic complications. The study demonstrated a WElkins device:

Delivered rapid brain cooling, on average 1.84°C reduction (range 0.9°C to 2.4°C) in brain temperature within 1 hour
Maintained a significant temperature gradient between the core and brain temperatures (average -1.6°C colder brain) throughout the hypothermic period to provide regional hypothermia yet minimize systemic complications
Learn more »

2. American Heart Association Guidelines 2010

Post-cardiac arrest care has received a great deal of focus in the AHA Guidelines 2010 and is probably the most important new area of emphasis. Included in the Guidelines are the following recommendations:

"Induced hypothermia, although best studied in survivors of ventricular fibrillation/pulseless ventricular tachycardia arrest, is generally recommended for adult survivors of cardiac arrest who remain unconscious, regardless of presenting rhythm."
"Hypothermia should be initiated as soon as possible after return of spontaneous circulation with a target temperature of 32°C-34°C.”
Learn more »

3. Hypothermia After Cardiac Arrest Study Group

In this multicenter trial with blinded assessment of the outcome, patients who had been resuscitated after cardiac arrest due to ventricular fibrillation were randomly assigned to undergo therapeutic hypothermia (target temperature, 32°C to 34°C, measured in the bladder) over a period of 24 hours or to receive standard treatment with normothermia. The results show that therapeutic mild hypothermia:

Increases chances of survival by 31%
Improves quality of survival by 41%
Protects tissue during ischemia by reducing oxygen metabolism and inflammation, while maintaining cell membrane integrity
(In the case of reperfusion injury) Reduces neuronal cell damage, free radical production and inflammatory responses, which are destructive to cells that have had blood flow restored after a period of ischemia
Learn more »

4. American Heart Association Circulation 2009

The AHA developed a decision module to capture costs and outcomes for patients with witnessed out-of-hospital ventricular fibrillation arrest who received conventional care or therapeutic hypothermia. In cardiac arrest survivors who met HACA trial criteria, therapeutic hypothermia with a cooling blanket was found to improve clinical outcomes with cost-effectiveness that is comparable to many economically acceptable health care interventions in the United States:

On average, post-arrest patients receiving therapeutic hypothermia gained an average of 0.66 quality-adjusted life years compared with conventional care, at an incremental cost of $31,254
Even at extreme estimates for costs, the cost-effectiveness of hypothermia remained less than the standard benchmark $100,000 per quality-adjusted life year
Learn more »