title: Multicenter clinical assessment of the Raumedic Neurovent-P intracranial pressure sensor: a report by the BrainIT group.
abstract: OBJECTIVE
  The aim of this study was to evaluate the robustness and zero-drift of an intracranial pressure sensor, Neurovent-P (Raumedic AG, Münchberg, Germany), when used in the clinical environment.
  
  
  METHODS
  A prospective multicenter trial, conforming to the International Organization for Standardization 14155 Standard, was conducted in 6 European BrainIT centers between July 2005 and December 2006. Ninety-nine catheters were used. The study was observational, followed by a centralized sensor bench test after catheter removal.
  
  
  RESULTS
  The mean recorded value before probe insertion was 0.17 +/- 1.1 mm Hg. Readings outside the range +/-1 mm Hg were recorded in only 3 centers on a total of 15 catheters. Complications were minimal and mainly related to the insertion bolt. The mean recorded pressure value at removal was 0.8 +/- 2.2 mm Hg. No relationship was identified between postremoval reading and length of monitoring. The postremoval bench test indicated the probability of a system failure, defined as a drift of more than 3 mm Hg, at a range between 12 and 17%.
  
  
  CONCLUSIONS
  The Neurovent-P catheter performed well in clinical use in terms of robustness. The majority of technical complications were associated with the bolt fixation technology. Adverse events were rare and clinically nonsignificant. Despite the earlier reported excellent bench test zero-drift rates, under the more demanding clinical conditions, zero-drift rate remains a concern with catheter tip strain gauge technology. This performance is similar, and not superior, to other intracranial pressure devices.
authors.affiliation: Department of Perioperative Medicine and Intensive Care, Ospedale San Gerardo, Monza, Italy. g.citerio@hsgerardo.org
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Citerio
authors.forename: Ian
authors.initials: I
authors.lastname: Piper
authors.forename: Iain R
authors.initials: IR
authors.lastname: Chambers
authors.forename: Davide
authors.initials: D
authors.lastname: Galli
authors.forename: Per
authors.initials: P
authors.lastname: Enblad
authors.forename: Karl
authors.initials: K
authors.lastname: Kiening
authors.forename: Arminas
authors.initials: A
authors.lastname: Ragauskas
authors.forename: Juan
authors.initials: J
authors.lastname: Sahuquillo
authors.forename: Barbara
authors.initials: B
authors.lastname: Gregson
mesh_terms: D001927:Brain Diseases / Q000175:diagnosis / Q000503:physiopathology*; D001930:Brain Injuries / Q000175:diagnosis / Q000503:physiopathology*; D002404:Catheterization; D019544:Equipment Failure Analysis; D005060:Europe; D006801:Humans; D007427:Intracranial Pressure; D008365:Manometry / Q000295:instrumentation*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013673:Technology Assessment, Biomedical; D014159:Transducers