Guided Application of Ventricular Catheters

Aesculap AG144 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

144

Conditions

Hydrocephalus

Interventions

Thomale-GuideDEVICE

Ventricular catheter placement with the Thomale-Guide instrument

Free-handOTHER

Ventricular catheter placement without a guidance (free-hand)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (9)

Charité University Hospital, Division of Pediatric Neurosurgery

Berlin, Germany

Trauma Hospital Berlin, Clinic for Neurosurgery

Berlin, Germany

University Hospital Düsseldorf, Clinic for Neurosurgery

Düsseldorf, Germany

Outcomes

Primary Outcomes

Rate of he primary successful ventricular catheter placement with a Grade I or Grade I b and location in the ipsilateral ventricle

Time frame: Within the first 40 days

Data from ClinicalTrials.gov

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