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:
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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:
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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:
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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:
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Further Reading
A Novel Head-Neck Cooling Device for Concussion Injury in Contact Sports
Wang H, Wang B, Jackson K, Miller C, Hasadsri L, Llano D, Rubin R, Zimmerman J, Johnson C, Sutton B.
Translational Neuroscience. 2015 Jan;6(1).
Wang H, Wang B, Jackson K, Miller C, Hasadsri L, Llano D, Rubin R, Zimmerman J, Johnson C, Sutton B.
Translational Neuroscience. 2015 Jan;6(1).
Rapid and Selective Cerebral Hypothermia Achieved Using a Cooling Helmet
Wang H, Olivero W, Lanzino G, Elkins W, Rose J, Honings D, Rodde M, Burnham J, Wang D.
Journal of Neurosurgery. 2004; 100, 272-277
Wang H, Olivero W, Lanzino G, Elkins W, Rose J, Honings D, Rodde M, Burnham J, Wang D.
Journal of Neurosurgery. 2004; 100, 272-277
Effects of Therapeutic Hypothermia on Inflammasome Signaling After Traumatic Brain Injury
Tomura S, de Rivero Vaccari JP, Keane RW, Bramlett HM, Dietrich WD.
Journal of Cerebral Blood Flow & Metabolism. 2012 Oct;32(10):1939-47.
Tomura S, de Rivero Vaccari JP, Keane RW, Bramlett HM, Dietrich WD.
Journal of Cerebral Blood Flow & Metabolism. 2012 Oct;32(10):1939-47.
Neuroprotective Mechanisms of Hypothermia in Brain Ischaemia
Yenari MA, Han HS.
Nature Reviews Neuroscience. 2012 Feb 22;13(4):267-78.
Yenari MA, Han HS.
Nature Reviews Neuroscience. 2012 Feb 22;13(4):267-78.
Mild Hyperthermia Worsens the Neuropathological Damage Associated with Mild Traumatic Brain Injury in Rats
Sakurai A, Atkins CM, Alonso OF, Bramlett HM, Dietrich WD.
Journal of Neurotrauma. January 20, 2012, 29(2): 313-321.
Sakurai A, Atkins CM, Alonso OF, Bramlett HM, Dietrich WD.
Journal of Neurotrauma. January 20, 2012, 29(2): 313-321.
Effects of Selective Brain Cooling in Patients with Severe TBI
Liu WG, Qiu WS, Zhang Y, Wang WM, Lu F, Yang XF.
The Journal of International Medical Research. 2006; 34: 58–64
Liu WG, Qiu WS, Zhang Y, Wang WM, Lu F, Yang XF.
The Journal of International Medical Research. 2006; 34: 58–64
Noninvasive Selective Brain Cooling by Head and Neck cooling is Protective in Severe TBI
Qiu W, Shen H, Zhang Y, Wang W, Liu W, Jiang Q, Luo M, Manou M.
Journal of Clinical Neuroscience. 2006 Dec;13(10):995-1000.
Qiu W, Shen H, Zhang Y, Wang W, Liu W, Jiang Q, Luo M, Manou M.
Journal of Clinical Neuroscience. 2006 Dec;13(10):995-1000.
A Military-Centered Approach to Neuroprotection for Traumatic Brain Injury
Shear DA, Tortella FC.
Frontiers in Neurology. 2013 Jun 12;4:73.
Shear DA, Tortella FC.
Frontiers in Neurology. 2013 Jun 12;4:73.
Prophylactic Hypothermia for Traumatic Brain Injury: a Quantitative Systematic Review
Fox JL, Vu EN, Doyle-Waters M, Brubacher JR, Abu-Laban R, Hu Z.
Canadian Journal of Emergency Medicine. 2010 Jul;12(4):355-64.
Fox JL, Vu EN, Doyle-Waters M, Brubacher JR, Abu-Laban R, Hu Z.
Canadian Journal of Emergency Medicine. 2010 Jul;12(4):355-64.
Case Report: Differential interhemispheric cooling and ICP compartmentalization in a patient with left ICA occlusion
Wang H, Wang, D, Lanzino G, Elkins W, Olivero W
Acta Neurochirurgica. 2006; 148: 681–683
Wang H, Wang, D, Lanzino G, Elkins W, Olivero W
Acta Neurochirurgica. 2006; 148: 681–683
Mild Therapeutic Hypothermia to Improve the Neurologic Outcome after Cardiac Arrest
The Hypothermia after Cardiac Arrest Study Group
The New England Journal of Medicine. 2002; 346: 549-556
The Hypothermia after Cardiac Arrest Study Group
The New England Journal of Medicine. 2002; 346: 549-556
Post-Traumatic Brain Hypothermia Provides Protection from Sensorimotor and Cognitive Behavioral Deficits
Bramlett HM, Green EJ, Dietrich WD, Busto R, Globus MY, Ginsberg MD.
Journal of Neurotrauma. 1995 Jun;12(3):289-98.
Bramlett HM, Green EJ, Dietrich WD, Busto R, Globus MY, Ginsberg MD.
Journal of Neurotrauma. 1995 Jun;12(3):289-98.
Post-Traumatic Brain Hypothermia Reduces Histopathological Damage Following Concussive Brain Injury in the Rat
Dietrich WD, Alonso O, Busto R, Globus MY, Ginsberg MD.
Acta Neuropathologica. 1994;87(3):250-8.
Dietrich WD, Alonso O, Busto R, Globus MY, Ginsberg MD.
Acta Neuropathologica. 1994;87(3):250-8.