GAVCA: Guided Application of Ventricular Catheters
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Thomale-Guide Positioning of ventricular catheter with the Thomale-Guide instrument |
Device: Thomale-Guide
Ventricular catheter placement with the Thomale-Guide instrument
|
| Other: Free-hand Ventricular catheter placement without a guidance (free-hand) |
Other: Free-hand
Ventricular catheter placement without a guidance (free-hand)
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charité University Hospital, Division of Pediatric Neurosurgery | Berlin | Germany | 13353 | |
| 2 | Trauma Hospital Berlin, Clinic for Neurosurgery | Berlin | Germany | ||
| 3 | University Hospital Düsseldorf, Clinic for Neurosurgery | Düsseldorf | Germany | ||
| 4 | Univeristätsmedizin Göttingen, Neurochirurgie | Göttingen | Germany | 37075 | |
| 5 | Medizinische Hochschule Hannover, Neurochirurgie | Hannover | Germany | 30625 | |
| 6 | Heidelberg University Hospital, Department of Neurosurgery | Heidelberg | Germany | ||
| 7 | Klinikum Kassel GmbH / Department of Neurosurgery | Kassel | Germany | ||
| 8 | Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery | Neubrandenburg | Germany | ||
| 9 | University Hospital Tübingen, Department of Neurosurgery | Tübingen | Germany |
Sponsors and Collaborators
- Aesculap AG
Investigators
- Principal Investigator: Ulrich W Thomale, PD Dr. med., Charite University, Berlin, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
- AAG-G-H1221