title: Local brain temperature reduction through intranasal cooling with the RhinoChill device: preliminary safety data in brain-injured patients.
abstract: OBJECTIVE
  Hypothermia is neuroprotectant but currently available cooling methods are laborious, invasive, and require whole-body cooling. There is a need for less invasive cooling of the brain. This study was conducted to assess the safety and efficacy of temperature reduction of the RhinoChill transnasal cooling device.
  
  
  METHODS
  We conducted a prospective single-arm safety and feasibility study of intubated patients for whom temperature reduction was indicated. After rhinoscopy, the device was activated for 1 hour. Brain, tympanic, and core temperatures along with vital signs and laboratory studies were recorded. All general and device-related adverse events were collected for the entire hypothermia treatment.
  
  
  RESULTS
  A total of 15 patients (mean age, 50.3 ± 17.1 years) were enrolled. Brain injury was caused by intracerebral hemorrhage, trauma, and ischemic stroke in equal numbers. Hypothermia was induced for fever control in 9 patients and for neuroprotection/intracranial pressure control in 6. Core temperature, brain temperature, and tympanic temperature were reduced an average of 1.1 ± 0.6°C (range, 0.3 to 2.1°C), 1.4 ± 0.4°C (range, 0.8 to 5.1°C), and 2.2 ± 2°C (range, 0.5 to 6.5°C), respectively. Only 2 patients did not achieve the goal of ≥1°C decrease in temperature. Brain temperature, tympanic temperature, and core temperature reductions were similar between the afebrile and febrile patients. There were no unanticipated adverse events and only 1 anticipated adverse event: hypertension in 1 subject that led to discontinuation of cooling after 30 minutes. There were no nasal complications.
  
  
  CONCLUSIONS
  Intranasal cooling with the RhinoChill device appears safe and effectively lowers brain and core temperatures. Further study is warranted to assess the efficacy of hypothermia through intranasal cooling for brain-injured patients.
authors.affiliation: Department of Neurology, University of Louisville School of Medicine, Louisville, KY 40202, USA. a0abou03@louisville.edu
authors.forename: Alex
authors.initials: A
authors.lastname: Abou-Chebl
authors.forename: Gene
authors.initials: G
authors.lastname: Sung
authors.forename: Denise
authors.initials: D
authors.lastname: Barbut
authors.forename: Michel
authors.initials: M
authors.lastname: Torbey
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001921:Brain / Q000503:physiopathology; D001930:Brain Injuries / Q000503:physiopathology / Q000628:therapy*; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D005334:Fever / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020521:Stroke / Q000503:physiopathology / Q000628:therapy*