Image Guided EVD Placement

Hamilton Health Sciences Corporation

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

External Ventricular Drain (EVD)Image Guidance

Interventions

Image Guided External Ventricular Drain Placement Using the NAV3 SystemDEVICE

Nav3 image guidance system used to assist with external ventricular drain placement

Free Hand External Ventricular Drain PlacementPROCEDURE

External ventricular drain will be placed with the standard free-hand technique

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Hamilton General Hospital

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

Study Feasibility

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

Time frame: 8 months

Secondary Outcomes

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.

Time frame: 8 months

Number of attempts

Number of attempts required to satisfactorily place the EVD

Time frame: 8 months

Complications

Occurrence of any complications or infections will be monitored

Time frame: 8 months

Data from ClinicalTrials.gov

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