Image Guided EVD Placement

Image-guided External Ventricular Drain Placement Trial: a Prospective Randomized-controlled Trial Pilot

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.

Study Overview

• Status: Not yet recruiting
• Conditions: External Ventricular Drain (EVD); Image Guidance
• Intervention / Treatment: Procedure: Free Hand External Ventricular Drain Placement; Device: Image Guided External Ventricular Drain Placement Using the NAV3 System

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Kesava Reddy; Phone Number: 905-521-0061; Email: reddy@hhsc.ca
• Study Contact Backup: Name: Ms. Jessy Moore, MSc; Phone Number: 289-686-8827; Email: moorej@hhsc.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
      • Contact: Dr. Kesava Reddy; Phone Number: 905-521-2100; Email: reddy@hhsc.ca
      • Contact: Jessy Moore; Phone Number: 289-686-8827; Email: moorej@hhsc.ca
      • Principal Investigator: Dr. Kesava Reddy
      • Sub-Investigator: Dr. Ezequiel Yasuda
      • Sub-Investigator: Dr. Mohamad Kesserwan
      • Sub-Investigator: Dr. Almunder Algird

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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	Device: Image Guided External Ventricular Drain Placement Using the NAV3 System; Nav3 image guidance system used to assist with external ventricular drain placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Feasibility	Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence)	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of external ventricular drain (EVD) placement	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.	8 months
Number of attempts	Number of attempts required to satisfactorily place the EVD	8 months
Complications	Occurrence of any complications or infections will be monitored	8 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Kakarla UK, Kim LJ, Chang SW, Theodore N, Spetzler RF. Safety and accuracy of bedside external ventricular drain placement. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS162-6; discussion ONS166-7. doi: 10.1227/01.neu.0000335031.23521.d0.
• Aljoghaiman M, Bergen B, Takroni R, Wang B, Eangles P, Farrokhyar F, Sharma S. Image-Guided versus Freehand Ventricular Drain Insertion: Systematic Review and Meta-analysis. World Neurosurg. 2022 Apr;160:85-93.e5. doi: 10.1016/j.wneu.2022.01.036. Epub 2022 Jan 13.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 15534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers.

De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No