Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial

NCT02048553 | Unknown

• 1 other identifier: 05092013
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite the widespread use of external ventricular drainage, revision rates and associated complications are reported between 10-40%. Current available image-guided techniques using stereotaxis, endoscopy or ultrasound for catheter placements remain time-consuming techniques. Recently, a phone-assisted guide with high precision has been described. The development of an easy-to-use, portable, image-guided system could reduce the need for multiple passes and improve the rate of accurate catheter placement. This study aim to compare prospectively in a randomized controlled manner the accuracy of the freehand pass technique versus an an easy-to-use, portable mini-tablet-assisted guide for ventriculostomy catheter placement. Methods/Design: This is a single center, prospective, randomized, trial with blinded endpoint (ventricle catheter tip location) assessment. Adult patients with the indication for ventriculostomy, as proven by computed tomography (CT), will be randomly assigned to the treatment group or the control group. In patients of the treatment group, ventriculostomy will be performed using a mini-tablet-guided assistance based on preoperative CT imaging. Patients in the control group will receive standard free-hand ventriculostomy using anatomical landmarks. The catheter may be placed for external drainage or internal (ventriculoperitoneal) shunting in both groups. The primary outcome measure is rate of correct placements of the ventricular catheter, defined as a score of 1 to 3 on grading system for catheter tip location on postoperative CT scan. Primary outcome will be determined by one of the authors (NS) blinded for treatment allocation. We aim to include 320 patients in 3 years. Secondary Outcome Measures include 1) Frequency of placements required, 2) Frequency of completed placements within the ventricle of the perforated part of the tip of the catheter, 3) Frequency of very early and early shunt failures (revision of the ventricular drainage within 24 hours / within three weeks, 4) Frequency and Percentage of complications (procedure-related and nonsurgical) within three weeks, 5) Length of the trajectories from the dura level to the foramen of Monroe, the angle in the coronal plane towards midline (a) and towards the target (b) at the respective entry point, 6) ventricle size (the frontal occipital horn ratio (FOHR) and the width of the lateral ventricle in the coronal plane between the medial wall of the corpus callosum and the septum), 7) Differences (angles, distance of catheter tip from target) on the tablet-guided planned and postoperative trajectory on control computer tomography within 48 hrs (CT). Discussion: Here, we present the study design of a single center prospective randomized controlled trial to investigate whether tablet-guided application ventriculostomy is superior to the standard free hand technique. The strengths of this study are: 1. the prospective, randomized interventional character testing a new easy-to handle guided versus free-hand ventricular catheter placement, and 2. the power calculation is based on catheter accuracy using an available grading system for catheter tip location and calculated with use of recent study results of our own population, supported by data from prominent studies.

Conditions

Hydrocephalus.

Keywords

ventriculostomy; complications in neurosurgery;catheter accuracy;

Outcome Measures

Primary Outcomes (2)

• Frequency and Percentage of correct placements of the ventricular catheter.

  Table 1. Grading system for catheter tip location Grade / Accuracy of placement / Location of catheter tip 1. Optimal/adequate Ipsilateral frontal horn, including tip of third ventricle 2. Suboptimal in noneloquent tissue Controlateral frontal horn or lateral ventricle/corpus callosum/interhemispheric fissure 3. Suboptimal in eloquent tissue Brainstem/cerebellum/internal capsule/basal ganglia/thalamus/occipital cortex/basal cisterns

  Assessed on postoperative cranial computer tomography, performed within 48 hours post intervention.

• Frequency and Percentage of acute ventricular revisions.

  2\) Frequency and Percentage of acute ventricular revisions (within 1 week for an improperly-placed catheter). Assessment is performed by a blinded investigator of the study.

  7 days

Secondary Outcomes (7)

• Frequency of placements required.

  During intervention.

• Frequency of correct placement.

  on postoperative cranial computer tomography with 48 hrs post intervention.

• Frequency of very early and early shunt failures

  within 24 hours / within the hospital stay

• Frequency and Percentage of complications

  From intervention to discharge.

• Length of the trajectories from the dura level to the foramen of Monroe

  Evaluated on postoperative cranial computer tomography with 48 hrs post intervention.

Study Arms (2)

Tablet-guided

EXPERIMENTAL

Guide-assisted ventriculostomy.

Procedure: Freehand

Freehand

EXPERIMENTAL

standard ventriculostomy.

Device: Tablet-guided ventriculostomy

Interventions

Tablet-guided ventriculostomy DEVICE

In patients of the treatment group, ventriculostomy will be performed using a mini-tablet-guided assistance based on preoperative CT imaging. Any patient meeting the inclusion criteria and not violating the exclusion criteria may participate in the TABGUIDE study and be randomized to either a guided or freehand ventriculostomy, thus defining the two distinct groups " guided " or " freehand ").

Also known as: TABGUIDE

Freehand

Freehand PROCEDURE

Patients in the control group will receive standard free-hand ventriculostomy using anatomical landmarks. The catheter may be placed for external drainage or internal (ventriculoperitoneal) shunting in both groups.

Tablet-guided

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years or older,
• Indication for a ventricular drainage (such as hydrocephalus, slit ventricles, pseudotumor cerebri).

You may not qualify if:

• Pregnancy,
• postoperative imaging not to be performed,
• frontal burr hole not available.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Division of Neurosurgery, Geneva University Hospitals, Geneva Neuroscience Center, Faculty of Medicine, University of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (1)

• Sarrafzadeh A, Smoll N, Schaller K. Guided (VENTRI-GUIDE) versus freehand ventriculostomy: study protocol for a randomized controlled trial. Trials. 2014 Dec 5;15:478. doi: 10.1186/1745-6215-15-478.

  PMID: 25480528 DERIVED

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Asita S Sarrafzadeh, MD

CONTACT

0041 22 37 28206; asita.sarrafzadeh@hcuge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurosurgery (Charité Berlin, Germany)

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: January 29, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

CH (1)