Guided Application of Ventricular Catheters

Not Applicable

Completed

• Conditions: Hydrocephalus
• Interventions: Other: Free-hand; Device: Thomale-Guide

• Registration Number: NCT01811589
• Lead Sponsor: Aesculap AG

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.

Study Timeline

• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-14
• Study Start: 2013-05
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free-hand	Free-hand	Ventricular catheter placement without a guidance (free-hand)
Thomale-Guide	Thomale-Guide	Positioning of ventricular catheter with the Thomale-Guide instrument

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Charité University Hospital, Division of Pediatric Neurosurgery; 🇩🇪 Berlin, Germany

University Hospital Düsseldorf, Clinic for Neurosurgery; 🇩🇪 Düsseldorf, Germany

Univeristätsmedizin Göttingen, Neurochirurgie; 🇩🇪 Göttingen, Germany

Dietrich-Bonhoeffer-Klinikum / Department of Neurosurgery; 🇩🇪 Neubrandenburg, Germany

Medizinische Hochschule Hannover, Neurochirurgie; 🇩🇪 Hannover, Germany

Klinikum Kassel GmbH / Department of Neurosurgery; 🇩🇪 Kassel, Germany

Heidelberg University Hospital, Department of Neurosurgery; 🇩🇪 Heidelberg, Germany

University Hospital Tübingen, Department of Neurosurgery; 🇩🇪 Tübingen, Germany

Trauma Hospital Berlin, Clinic for Neurosurgery; 🇩🇪 Berlin, Germany