Clinical trial NCT05639036: Image Guided EVD Placement
Official title: Image-guided External Ventricular Drain Placement Trial: a Prospective Randomized-controlled Trial Pilot
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: External Ventricular Drain (EVD)
Image Guidance
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study Feasibility
timeFrame: 8 months
Secondary outcomes:
measure: Accuracy of external ventricular drain (EVD) placement
timeFrame: 8 months
measure: Number of attempts
timeFrame: 8 months
measure: Complications
timeFrame: 8 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Dr. Kesava Reddy
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.