Guided Application of Ventricular Catheters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-01-31

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.

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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.

Conditions

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Hydrocephalus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Thomale-Guide

Positioning of ventricular catheter with the Thomale-Guide instrument

Group Type EXPERIMENTAL

Thomale-Guide

Intervention Type DEVICE

Ventricular catheter placement with the Thomale-Guide instrument

Free-hand

Ventricular catheter placement without a guidance (free-hand)

Group Type OTHER

Free-hand

Intervention Type OTHER

Ventricular catheter placement without a guidance (free-hand)

Interventions

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Thomale-Guide

Ventricular catheter placement with the Thomale-Guide instrument

Intervention Type DEVICE

Free-hand

Ventricular catheter placement without a guidance (free-hand)

Intervention Type OTHER

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No