Image Guided EVD Placement
- Conditions
- External Ventricular Drain (EVD)Image Guidance
- Interventions
- Procedure: Free Hand External Ventricular Drain PlacementDevice: Image Guided External Ventricular Drain Placement Using the NAV3 System
- Registration Number
- NCT05639036
- Lead Sponsor
- Hamilton Health Sciences Corporation
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Control-Free Hand External Ventricular Drain Placement Free Hand External Ventricular Drain Placement This group will receive an external ventricular drain placed using the standard free-hand technique Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System 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
- Primary Outcome Measures
Name Time Method Study Feasibility 8 months Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence)
- Secondary Outcome Measures
Name Time Method Number of attempts 8 months Number of attempts required to satisfactorily place the EVD
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.
Complications 8 months Occurrence of any complications or infections will be monitored
Trial Locations
- Locations (1)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada