Guided Application of Ventricular Catheters

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Multi-center Trial Comparing the Ventricular Catheter Location Between Instrument Guided and Freehand Placement.

Conditions
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Hydrocephalus

Intervention / Treatment
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* Device: Thomale-Guide
* Other: Free-hand


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thomale-Guide<br>Positioning of ventricular catheter with the Thomale-Guide instrument | Device: Thomale-Guide<br>* Ventricular catheter placement with the Thomale-Guide instrument<br>|
| Other: Free-hand<br>Ventricular catheter placement without a guidance (free-hand) | Other: Free-hand<br>* Ventricular catheter placement without a guidance (free-hand)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventricular catheter, hydrocephalus, shunt, brain disease