Not provided
Not provided
Not provided
Not provided
Not provided
Limited resources available. Study unable to begin.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-Free Hand External Ventricular Drain Placement | Active Comparator | 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 | Experimental | This group will receive an external ventricular drain placed using the assistance of the Stryker NAV3 image guidance system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image Guided External Ventricular Drain Placement Using the NAV3 System | Device | Nav3 image guidance system used to assist with external ventricular drain placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Feasibility | Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence) | 8 months |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Kesava Reddy | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18728595 | Background | 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. | |
| 35033689 | Background | 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. |
Not provided
Not provided
Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers.
De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Free Hand External Ventricular Drain Placement | Procedure | External ventricular drain will be placed with the standard free-hand technique |
|
| 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 |