Hydrocephalus Clinical Trial
Official title:
Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can achieve a more precise placement of ventricular catheters than the standard free-hand placement technique.
Free-hand placement of ventricular catheters (VC) is reported to be inaccurate in 10-40%.
Furthermore, there is evidence that the quality of VC positioning is correlating with the
risk for proximal shunt obstruction. Ultrasound or neuronavigation are used in order to
improve to placement. However, they are associated with significant technical efforts and
increased time.
In this study a simple instrument assisted by a smart phone application software is used in
order to achieve precise placement of ventricular catheters. The results are compared with
the standard free-hand procedure. Patients requiring a ventricular catheter are randomized to
one of the two treatments. The primary outcome parameter is a qualitative and quantitative
assessment of the position of the ventricular catheter on a post-operative image. The
evaluation of the primary criteria is performed by a radiologist blinded to the randomization
arm.
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