• Trials · Jan 2013

    Randomized Controlled Trial Multicenter Study Comparative Study

    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.

    • Andreas Schaumann and Ulrich-Wilhelm Thomale.
    • Department of Neurosurgery/Paediatric Neurosurgery, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. uthomale@charite.de.
    • Trials. 2013 Jan 1;14:428.

    BackgroundThe 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/DesignThis 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.DiscussionThe 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 RegistrationThe GAVCA trial is registered at ClinicalTrials.gov under the number NCT01811589.

      Pubmed     Free full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…

Want more great medical articles?

Keep up to date with a free trial of metajournal, personalized for your practice.
1,694,794 articles already indexed!

We guarantee your privacy. Your email address will not be shared.