NCT01811589

Guided Application of Ventricular Catheters

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hydrocephalus

Interventions

Type	Name	Description
DEVICE	Thomale-Guide	Ventricular catheter placement with the Thomale-Guide instrument
OTHER	Free-hand	Ventricular catheter placement without a guidance (free-hand)

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-03-14
• Last updated: 2019-06-06

Locations

9 sites across 1 country: Germany