External Ventricular Drain (EVD), Image Guidance
Conditions
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.
Interventions
DEVICEImage Guided External Ventricular Drain Placement Using the NAV3 System
Nav3 image guidance system used to assist with external ventricular drain placement
PROCEDUREFree Hand External Ventricular Drain Placement
External ventricular drain will be placed with the standard free-hand technique
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Feasibility | 8 months | Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of attempts | 8 months | Number of attempts required to satisfactorily place the EVD |
| Complications | 8 months | Occurrence of any complications or infections will be monitored |
Countries
Canada
Outcome results
None listed