Image Guided EVD Placement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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External Ventricular Drain (EVD), Image Guidance

Intervention / Treatment
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* Device: Image Guided External Ventricular Drain Placement Using the NAV3 System
* Procedure: Free Hand External Ventricular Drain Placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control-Free Hand External Ventricular Drain Placement<br>This group will receive an external ventricular drain placed using the standard free-hand technique | Procedure: Free Hand External Ventricular Drain Placement<br>* External ventricular drain will be placed with the standard free-hand technique<br>|
| Experimental: Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System<br>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<br>* Nav3 image guidance system used to assist with external ventricular drain placement<br>|

What is the study measuring?
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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 |