Image Guided EVD Placement

Hamilton Health Sciences (HHS)

Status: Withdrawn

Conditions: Image Guidance; External Ventricular Drain (EVD)

Treatments: Device: Image Guided External Ventricular Drain Placement Using the NAV3 System; Procedure: Free Hand External Ventricular Drain Placement

Study type: Interventional

Funder types: Other

Identifiers

NCT05639036

15534

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Control-Free Hand External Ventricular Drain Placement

Active Comparator group

Description:

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

Treatment:

Procedure: Free Hand External Ventricular Drain Placement

Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System

Experimental group

Description:

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

Treatment:

Device: Image Guided External Ventricular Drain Placement Using the NAV3 System