Guided Application of Ventricular Catheters (GAVCA)

Aesculap

Status: Completed

Conditions: Hydrocephalus

Treatments: Device: Thomale-Guide; Other: Free-hand

Study type: Interventional

Funder types: Industry

Identifiers

NCT01811589

AAG-G-H1221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

Thomale-Guide

Experimental group

Description:

Positioning of ventricular catheter with the Thomale-Guide instrument

Treatment:

Device: Thomale-Guide

Free-hand

Other group

Description:

Ventricular catheter placement without a guidance (free-hand)

Treatment:

Other: Free-hand