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Clinical trial of a novel surface cooling system for fever control in neurocritical care patients*

Mayer, Stephan A. MD; Kowalski, Robert G. BS; Presciutti, Mary RN; Ostapkovich, Noeleen D. MS; McGann, Elaine RN; Fitzsimmons, Brian-Fred MD; Yavagal, Dileep R. MD; Du, Y Evelyn PhD; Naidech, Andrew M. MD; Janjua, Nazli A. MD; Claassen, Jan MD; Kreiter, Kurt T. PhD; Parra, Augusto MD; Commichau, Christopher MD

Critical Care Medicine:
doi: 10.1097/01.CCM.0000147441.39670.37
Neurologic Critical Care
Abstract

Objective: To compare the efficacy of a novel water-circulating surface cooling system with conventional measures for treating fever in neuro-intensive care unit patients.

Design: Prospective, unblinded, randomized controlled trial.

Setting: Neurologic intensive care unit in an urban teaching hospital.

Patients: Forty-seven patients, the majority of whom were mechanically ventilated and sedated, with fever ≥38.3°C for >2 consecutive hours after receiving 650 mg of acetaminophen.

Interventions: Subjects were randomly assigned to 24 hrs of treatment with a conventional water-circulating cooling blanket placed over the patient (Cincinnati SubZero, Cincinnati OH) or the Arctic Sun Temperature Management System (Medivance, Louisville CO), which employs hydrogel-coated water-circulating energy transfer pads applied directly to the trunk and thighs.

Measurements and Main Results: Diagnoses included subarachnoid hemorrhage (60%), cerebral infarction (23%), intracerebral hemorrhage (11%), and traumatic brain injury (4%). The groups were matched in terms of baseline variables, although mean temperature was slightly higher at baseline in the Arctic Sun group (38.8 vs. 38.3°C, p = .046). Compared with patients treated with the SubZero blanket (n = 24), Arctic Sun-treated patients (n = 23) experienced a 75% reduction in fever burden (median 4.1 vs. 16.1 C°-hrs, p = .001). Arctic Sun-treated patients also spent less percent time febrile (T ≥38.3°C, 8% vs. 42%, p < .001), spent more percent time normothermic (T ≤37.2°C, 59% vs. 3%, p < .001), and attained normothermia faster than the SubZero group median (2.4 vs. 8.9 hrs, p = .008). Shivering occurred more frequently in the Arctic Sun group (39% vs. 8%, p = .013).

Conclusion: The Arctic Sun Temperature Management System is superior to conventional cooling-blanket therapy for controlling fever in critically ill neurologic patients.

Author Information

From the Neurological Intensive Care Unit, Departments of Neurology (SAM, RGK, NDO, BFF, DRY, AMN, NAJ, JC, KTK, AP, CC) and Neurosurgery (SAM, BFF, AP, CC), College of Physicians and Surgeons, the Department of Biostatistics (ED), School of Public Health, Columbia University, and the Department of Nursing (MP, EM), New York Presbyterian Hospital, New York, NY.

This study was supported by an unrestricted research grant from Medivance Inc. (SAM). The sponsor played no role in the trial design, data collection and analysis, or preparation of this manuscript. Dr. Mayer has received speaking honoraria from Medivance, Inc.

Address requests for reprints to: Stephan A Mayer, MD, Division of Critical Care Neurology, Neurological Institute, 710 West 168th Street, Unit 39, New York, NY 10032. E-mail: sam14@columbia.edu

© 2004 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins