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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thomale-Guide | Experimental | Positioning of ventricular catheter with the Thomale-Guide instrument |
|
| Free-hand | Other | Ventricular catheter placement without a guidance (free-hand) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thomale-Guide | Device | Ventricular catheter placement with the Thomale-Guide instrument |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle | Within the first 40 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich W Thomale, PD Dr. med. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University Hospital, Division of Pediatric Neurosurgery | Berlin | 13353 | Germany | |||
| Trauma Hospital Berlin, Clinic for Neurosurgery |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23089936 | Background | 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. | |
| 28973670 | Result | 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. |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Free-hand |
| Other |
Ventricular catheter placement without a guidance (free-hand) |
|
| Berlin |
| Germany |
| University Hospital Düsseldorf, Clinic for Neurosurgery | Düsseldorf | Germany |
| Univeristätsmedizin Göttingen, Neurochirurgie | Göttingen | 37075 | Germany |
| Medizinische Hochschule Hannover, Neurochirurgie | Hanover | 30625 | Germany |
| Heidelberg University Hospital, Department of Neurosurgery | Heidelberg | Germany |
| Klinikum Kassel GmbH / Department of Neurosurgery | Kassel | Germany |
| Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery | Neubrandenburg | Germany |
| University Hospital Tübingen, Department of Neurosurgery | Tübingen | Germany |
| 24330776 | Derived | 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. |