Guided Application of Ventricular Catheters (GAVCA) - multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail

BACKGROUND: The standard technique for the placement of ventricular catheters (VC) comprises a high proportion of malpositioning of the catheter (12.5 to 40%). Technical advances such as neuronavigation or ultrasound have been shown to increase the accuracy of the procedure. Since these means result in significant technical and time consuming efforts, they are used for selected cases only. In order to simplify the controlled placement of ventricular catheters a newly developed smartphone assisted guiding tool has been introduced. In this study the efficacy and safety of this guiding tool is determined. METHODS/DESIGN: This study is a multicentre, randomised, controlled trial. A total of 144 patients planned for an elective shunting procedure will be enrolled throughout 10 study centres within two years. The primary objective of the trial is to show the superiority of the guided placement in comparison to the standard freehand technique of ventricular catheter application. Patients will be followed up for 30 days after the operation in regard to image-based evaluation of the catheter position as well as possible shunt dysfunction and complications. DISCUSSION: The Guided Application of Ventricular Catheters (GAVCA) trial compares the guided catheter positioning with the standard freehand technique of catheter placement in hydrocephalic patients. If superiority is shown, the standard technique may be changed with the advantage of a more reliable and safer positioning of the ventricular catheter with just a slight effort in time and pre-operative planning. TRIAL REGISTRATION: The GAVCA trial is registered at ClinicalTrials.gov under the number NCT01811589.