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Multicenter Clinical Assessment of the Raumedic Neurovent‐P Intracranial Pressure Sensor: A Report By the Brainit Group

Lookup NU author(s): Dr Iain Chambers, Dr Barbara Gregson

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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%. CONCLUSION: 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.


Publication metadata

Author(s): Citerio G, Piper I, Chambers IR, Galli D, Enblad P, Kiening K, Ragauskas A, Sahuquillo J, Gregson B

Publication type: Article

Publication status: Published

Journal: Neurosurgery

Year: 2008

Volume: 63

Issue: 6

Pages: 1152-1158

ISSN (print): 0148-396X

ISSN (electronic): 1524-4040

Publisher: Lippincott Williams & Wilkins

URL: http://dx.doi.org/10.1227/01.NEU.0000335148.87042.D7

DOI: 10.1227/01.NEU.0000335148.87042.D7

PubMed id: 19057328


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