title: Safety evaluation of nasopharyngeal cooling (RhinoChill®) in stroke patients: an observational study.
abstract: BACKGROUND
  New technologies for therapeutic cooling have become available. The objective of our study was to investigate the safety of nasopharyngeal cooling with the RhinoChill(®) device in stroke patients, focusing on systemic and neurovital parameters.
  
  
  METHODS
  In this prospective observational study, consecutive patients with severe ischemic or hemorrhagic stroke who underwent intracranial pressure (ICP) and brain temperature monitoring have been enrolled. Ten patients who were treated with the RhinoChill(®) device were analyzed. Brain and bladder temperature and systemic and neurovital parameters were monitored continuously. Additional evaluations of safety included bleeding complications and otolaryngological examinations.
  
  
  RESULTS
  Baseline brain temperature of 36.7 °C (SD 0.9) decreased by an average of 1.21 °C (SD 0.46) within 1 h, the effect of brain temperature decrease ranged from a maximum of 2 °C (patients 3 and 7) to a minimum of 0.6 °C (patient 4). Within the first several minutes after initiating RhinoChill(®) treatment, 3 of 10 patients experienced an increase in systolic arterial pressure by 30, 30, and 53 mmHg, respectively. Heart rate rose as well (mean 3 bpm, SD 2.9). ICP and oxygen saturation were unaffected by the treatment. We observed 1 bleeding complication in the control CT scan of patient 10. Rhinoscopical findings 3 days after nasopharyngeal cooling and at the follow-up (>6 months) and a 16-item smell test were normal.
  
  
  CONCLUSIONS
  The RhinoChill(®) system cools the brain efficiently. However, steep increases in blood pressure raise serious concerns regarding the safety of its use in stroke patients.
authors.affiliation: Department of Neurology, Heidelberg University, Im Neuenheimer Feld 400, 69120, Heidelberg, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Poli
authors.forename: Jan
authors.initials: J
authors.lastname: Purrucker
authors.forename: Miriam
authors.initials: M
authors.lastname: Priglinger
authors.forename: Marek
authors.initials: M
authors.lastname: Sykora
authors.forename: Jennifer
authors.initials: J
authors.lastname: Diedler
authors.forename: André
authors.initials: A
authors.lastname: Rupp
authors.forename: Cem
authors.initials: C
authors.lastname: Bulut
authors.forename: Werner
authors.initials: W
authors.lastname: Hacke
authors.forename: Christian
authors.initials: C
authors.lastname: Hametner
mesh_terms: D000368:Aged; D062186:Arterial Pressure / Q000502:physiology; D001831:Body Temperature / Q000502:physiology; D001921:Brain / Q000502:physiology; D002545:Brain Ischemia / Q000628:therapy*; D002543:Cerebral Hemorrhage / Q000628:therapy*; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D007427:Intracranial Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods*; D009305:Nasopharynx / Q000000981:diagnostic imaging / Q000502:physiology; D011446:Prospective Studies; D011859:Radiography; D020521:Stroke / Q000628:therapy*; D016896:Treatment Outcome
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