Clinical trial NCT01811589: Guided Application of Ventricular Catheters
Official title: Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrocephalus
Keywords: ventricular catheter, hydrocephalus, shunt, brain disease
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients requiring a permanent ventricular catheter for the treatment of CSF (cerebrospinal fluid) - circulation disorder or another disease (ventricular shunt oder Ommaya/Rickham-Reservoir)
* Frontal occipital horn ratio (FOHR) \< 0.5
* Use of a new puncture channel
* Frontal access to the ventricles
* Patient´s informed consent

Exclusion Criteria:

* Known unevenness of the skull at the entry point
* Slit ventricles; Frontal and occipital horn width ratio (FOHWR) \< 0.05
* Participation in another clinical trial with interfering endpoints

Primary outcomes:
measure: Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle
timeFrame: Within the first 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Hospital, Division of Pediatric Neurosurgery
city: Berlin
country: Germany
facility: Trauma Hospital Berlin, Clinic for Neurosurgery
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf, Clinic for Neurosurgery
city: Göttingen
country: Germany
facility: Univeristätsmedizin Göttingen, Neurochirurgie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Neurochirurgie
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital, Department of Neurosurgery
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH / Department of Neurosurgery
city: Neubrandenburg
country: Germany
facility: Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery
city: Tübingen
country: Germany
facility: University Hospital Tübingen, Department of Neurosurgery
Study officials:
affiliation: Charite University, Berlin, Germany
name: Ulrich W Thomale, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomale UW, Knitter T, Schaumann A, Ahmadi SA, Ziegler P, Schulz M, Miethke C. Smartphone-assisted guide for the placement of ventricular catheters. Childs Nerv Syst. 2013 Jan;29(1):131-9. doi: 10.1007/s00381-012-1943-1. Epub 2012 Oct 23.
citation: Thomale UW, Schaumann A, Stockhammer F, Giese H, Schuster D, Kastner S, Ahmadi AS, Polemikos M, Bock HC, Golz L, Lemcke J, Hermann E, Schuhmann MU, Beez T, Fritsch M, Orakcioglu B, Vajkoczy P, Rohde V, Bohner G. GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique. Neurosurgery. 2018 Aug 1;83(2):252-262. doi: 10.1093/neuros/nyx420.
citation: Schaumann A, Thomale UW. 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. Trials. 2013 Dec 12;14:428. doi: 10.1186/1745-6215-14-428.