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Image Guided EVD Placement

Sponsor
Hamilton Health Sciences Corporation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05639036
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine if use of the Stryker Nav3 image guidance system offers superior results in external ventricular drain (EVD) placement compared to the standard free-hand technique.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Image Guided External Ventricular Drain Placement Using the NAV3 System
  • Procedure: Free Hand External Ventricular Drain Placement
 N/A

Detailed Description

An external ventricular drain (EVD) is a small tube that is placed into a space in the brain called a ventricle. This is done to drain fluid in the brain that sometimes builds up as a result of surgery or a traumatic brain injury/accident. This is one of most commonly performed procedures in Neurosurgery and is done bedside, not in the operating room. Typically, surgeons will use the "free-hand" technique to place these drains which involves relying on a CT scan, which shows the structures inside of the brain, and their knowledge of the anatomy of the brain and where the EVD should be placed. Image-guidance systems exist which create real time imaging of the patients brain and can act like a GPS to help guide the placement of the EVD in the correct spot. This trial is planned to determine if using the image guidance system does offer improved accuracy in EVD placement, lowering the number of attempts required and therefore the amount of time spent placing the EVD and risk of complications and infections. A pilot study will be done first, using a convenience sample at the Hamilton General Hospital to determine the feasibility of running a larger scale trial in the future.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Image-guided External Ventricular Drain Placement Trial: a Prospective Randomized-controlled Trial Pilot
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control-Free Hand External Ventricular Drain Placement

This group will receive an external ventricular drain placed using the standard free-hand technique

Procedure: Free Hand External Ventricular Drain Placement
External ventricular drain will be placed with the standard free-hand technique
Experimental: Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System

This group will receive an external ventricular drain placed using the assistance of the Stryker NAV3 image guidance system

Procedure: Image Guided External Ventricular Drain Placement Using the NAV3 System
Nav3 image guidance system used to assist with external ventricular drain placement

Outcome Measures

Primary Outcome Measures

  1. Study Feasibility [8 months]

    Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence)

Secondary Outcome Measures

  1. Accuracy of external ventricular drain (EVD) placement [8 months]

    Use of Kakarla grading system. This system uses a scale of 1 to 3, with 1 being optimal/satisfactory EVD placement, 2 being suboptimal EVD placement with the tip being placed in non-eloquent tissue, and 3 being suboptimal EVD placement with the tip being placed in eloquent tissue.

  2. Number of attempts [8 months]

    Number of attempts required to satisfactorily place the EVD

  3. Complications [8 months]

    Occurrence of any complications or infections will be monitored

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • patients requiring EVD placement

  • patients who can safely and reasonably be randomized to either study arm

  • patients with available pre-procedural head CT

  • written/verbal consent obtained

Exclusion Criteria:

  • patients with very small ventricles/distorted ventricular anatomy from traumatic brain injury (ie it is not reasonable to randomize the patient)

  • scenarios where the EVD must be inserted immediately and there is not time to obtain consent

  • scenarios where bedside image guidance system (NAV3) is unavailable

  • subjects medically or neurologically unstable to obtain pre-EVD CT scan

  • EVD revisions on ipsilateral side during same admission

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hamilton General Hospital Hamilton Ontario Canada L8L 2X2

Sponsors and Collaborators

  • Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Dr. Kesava Reddy, Hamilton Health Sciences Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT05639036
Other Study ID Numbers:
  • 15534
First Posted:
Dec 6, 2022
Last Update Posted:
Dec 6, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 6, 2022