Dataset Information

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.

ABSTRACT: 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.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.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.The GAVCA trial is registered at ClinicalTrials.gov under the number NCT01811589.

SUBMITTER: Schaumann A

PROVIDER: S-EPMC3866392 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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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.

Schaumann Andreas A Thomale Ulrich-Wilhelm UW

Trials 20131212

<h4>Background</h4>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 ...[more]

PMID: 24330776

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Project description:Despite the widespread use of external ventricular drainage, revision rates, and associated complications are reported between 10 and 40%. Current available image-guided techniques using stereotaxy, endoscopy, or ultrasound for catheter placements remain time-consuming techniques. Recently, a smartphone-assisted guide with high precision has been described. The development of an easy-to-use, portable, image-guided system could reduce the need for multiple passes and improve the rate of accurate catheter placement. This study aims to prospectively compare in a randomized controlled manner the accuracy of the freehand pass technique versus an easy-to-use, portable, adjustable guiding device for ventriculostomy catheter placement.This is a single center, prospective, randomized trial with a blinded endpoint (ventricular catheter tip location) assessment. Adult patients with the indication for ventriculostomy, as proven by computed tomography (CT), will be randomly assigned to the treatment group or the control group. For patients in the treatment group, ventriculostomy will be performed using an adjustable guiding device and DICOM (Digital Imaging and Communications in Medicine) image-reading software assistance (for example, using a mini-tablet) based on preoperative CT imaging.Patients in the control group will receive standard freehand ventriculostomy using anatomical landmarks. The catheter may be placed for external drainage or internal (ventriculoperitoneal) shunting in both groups. The primary outcome measure is the rate of correct placements of the ventricular catheter, defined as a score of 1 to 3 on grading system for catheter tip location on a postoperative CT scan. Participants will be followed for the duration of hospital stay, an expected average of two weeks. The primary outcome will be determined by one of the authors blinded to the treatment allocation. We aim to include 236 patients in three years. Secondary outcome measures include: frequency of placements required, frequency of completed placements within the ventricle of the perforated part of the catheter tip, frequency of very early and early shunt failures (revision of the ventricular drainage within 24 hours and within the hospital stay), frequency and percentage of complications (procedure-related and nonsurgical) at discharge.This is the study design of a single center, prospective, randomized controlled trial to investigate whether guided ventriculostomy is superior to the standard freehand technique. One strength of this study is the prospective, randomized, interventional type of study testing a new easy-to-handle guided versus freehand ventricular catheter placement. A second strength of this study is that the power calculation is based on catheter accuracy using an available grading system for catheter tip location, and is calculated with the use of recent study results of our own population, supported by data from prominent studies.Clinicaltrials.gov identifier: NCT02048553 (registered on 28 January 2014).

Dataset Information

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.

Publications

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.

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