Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University Hospital, Geneva
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Frequency and Percentage of acute ventricular revisions.
Study Overview
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.
Detailed Description
Methods Design The Tablet-guided versus freehand ventriculostomy (TABGUIDE) study will be performed as a 2-arm randomized controlled single-center trial to compare an intervention group using a guided placement of a ventricular catheter to a control group receiving standard (free-hand) ventriculostomy with blinded endpoint (catheter tip location) assessment.
Setting The present study is in compliance with the Helsinki Declaration. The protocol of this study was approved by the Ethics Committee on Human Research (CER) of the Medical Faculty of the University of Geneva, Switzerland (reference number: CER 13-175). At the planned start of the study at 01. March 2014, the study center will start randomization.
Randomization The randomization will start as soon as possible after consent to the study has been obtained. 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 ". Online randomization will be performed by the treating physician in the study center using permuted blocks, to ensure an equal number of patients in both study arms.
Interventions - Surgical technique
The study is conducted in the neurosurgical department of a swiss single center university hospital in adult patients with indication for a ventricular drainage (such as hydrocephalus, slit ventricles, pseudotumor cerebri). Data management and monitoring will be performed by the Geneva study center and statistical analysis by one of the authors (NS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: 18 years or older,
- •Indication for a ventricular drainage (such as hydrocephalus, slit ventricles, pseudotumor cerebri).
Exclusion Criteria
- •Pregnancy,
- •Concurrent participation in another interventional trial (participation in an observational trial is not an exclusion criteria),
- •postoperative imaging not to be performed,
- •frontal burr hole not available.
Arms & Interventions
Tablet-guided
Guide-assisted ventriculostomy.
Intervention: Freehand (Procedure)
Freehand
standard ventriculostomy.
Intervention: Tablet-guided ventriculostomy (Device)
Outcomes
Primary Outcomes
Frequency and Percentage of acute ventricular revisions.
Time Frame: 7 days
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.
Frequency and Percentage of correct placements of the ventricular catheter.
Time Frame: Assessed on postoperative cranial computer tomography, performed within 48 hours post intervention.
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
Secondary Outcomes
- 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.)
- ventricle size(Evaluated on postoperative cranial computer tomography with 48 hrs post intervention.)
- Differences on the planned and postoperative trajectories.(Evaluated on postoperative cranial computer tomography with 48 hrs post intervention.)
Investigators
Sarrafzadeh Asita
Professor of Neurosurgery (Charité Berlin, Germany)
University Hospital, Geneva