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

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ClinicalTrials.gov Identifier: NCT02048553
Recruitment Status : Unknown
Verified January 2014 by Sarrafzadeh Asita, University Hospital, Geneva.
Recruitment status was:  Not yet recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
Sarrafzadeh Asita, University Hospital, Geneva

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.


Condition or disease Intervention/treatment Phase
Hydrocephalus. Device: Tablet-guided ventriculostomy Procedure: Freehand Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial
Study Start Date : March 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arm Intervention/treatment
Experimental: Tablet-guided
Guide-assisted ventriculostomy.
Procedure: Freehand
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.

Experimental: Freehand
standard ventriculostomy.
Device: Tablet-guided ventriculostomy
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 ").
Other Name: TABGUIDE




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Frequency of placements required. [ Time Frame: During intervention. ]
    1) Frequency of placements required.

  2. Frequency of correct placement. [ Time Frame: on postoperative cranial computer tomography with 48 hrs post intervention. ]
    2) Frequency of completed placements within the ventricle of the perforated part of the catheter,

  3. Frequency of very early and early shunt failures [ Time Frame: within 24 hours / within the hospital stay ]
    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 [ Time Frame: From intervention to discharge. ]
    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 [ Time Frame: Evaluated on postoperative cranial computer tomography with 48 hrs post intervention. ]
    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 [ Time Frame: Evaluated on postoperative cranial computer tomography with 48 hrs post intervention. ]
    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 on the planned and postoperative trajectories. [ Time Frame: Evaluated on postoperative cranial computer tomography with 48 hrs post intervention. ]
    Differences (angles, distance of catheter tip from target) on the tablet-guided planned and postoperative trajectories.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048553


Contacts
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Contact: Asita S Sarrafzadeh, MD 0041 22 37 28206 asita.sarrafzadeh@hcuge.ch

Locations
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Switzerland
Division of Neurosurgery, Geneva University Hospitals, Geneva Neuroscience Center, Faculty of Medicine, University of Geneva Not yet recruiting
Geneva, Switzerland, 1211
Contact: Asita S Sarrafzadeh, MD       asita.sarrafzadeh@hcuge.ch   
Principal Investigator: Asita S Sarrafzadeh, MD         
Sponsors and Collaborators
University Hospital, Geneva

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sarrafzadeh Asita, Professor of Neurosurgery (Charité Berlin, Germany), University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02048553     History of Changes
Other Study ID Numbers: 05092013
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Keywords provided by Sarrafzadeh Asita, University Hospital, Geneva:
ventriculostomy; complications in neurosurgery;catheter accuracy;
Additional relevant MeSH terms:
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Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases