Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05931991 |
Other study ID # |
Bullseye EVD |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 7, 2023 |
Est. completion date |
November 2025 |
Study information
Verified date |
May 2024 |
Source |
Sunnybrook Health Sciences Centre |
Contact |
Cari Whyne, PhD, FIOR |
Phone |
416-480-6100 |
Email |
cari.whyne[@]sunnybrook.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The placement of external ventricular drainage (EVD) is a life-saving procedure used to
relieve high pressures in the brain. Often performed at the bedside, a small tube (catheter)
is inserted into one ventricle of the brain to drain cerebrospinal fluid and release the
pressure build up. In standard practice, EVDs are placed freehand and initial catheter
malpositioning occurs in up to ~60% of procedures. Currently, there are no adequate means to
verify the position of the catheter before insertion which is a significant impediment to
ensure accurate positioning. This non-interventional study aims to validate a novel
technology, Bullseye EVD, for verifying the position of the EVD catheter during these
emergency procedures.
Description:
External ventricular drainage (EVD) is a life-saving procedure used to release cerebrospinal
fluid and relieve elevated intracranial pressure due to acute hydrocephalus, often secondary
to subarachnoid hemorrhage, spontaneous intracerebral hemorrhage or traumatic brain injury
(TBI). To drain cerebrospinal fluid (CSF) from the ventricular system and relieve pressure on
the brain, a catheter is inserted into the ipsilateral frontal horn of the lateral ventricle
(IFHLV) close to the Foramen of Monro (FoM). Twist-drill trephination is utilized to create a
frontal burr hole at Kocher's point, approximately 11.5cm superior to the nasion and 2-3cm
lateral of the midline. The dura is perforated, and the catheter is inserted with a rigid
stylus. The current standard of care is a freehand technique which is often performed by
neurosurgeons at the bedside in the ICU. It relies on surface anatomical landmarks to guide
the catheter trajectory towards the FoM perpendicular to the calvarial slope at Kocher's
point. However, the freehand technique is challenging to accurately perform, often requiring
multiple passes of the catheter through the brain, with trajectory deviation most critical to
malpositioning. Up to 24% of malpositioned EVDs require revision or reinsertion which can
significantly increase catheter-associated infection. Up to 45.5% of EVD procedures require
multiple passes for successful catheter insertion (6). This can lead to hemorrhage along the
catheter tract (up to 34%, catheter dysfunction (up to 38%, and catheter-associated infection
(up to 36% which increase EVD-associated health care costs (up to 20%). EVD malpositioning
outside of the IFHLV (up to 60%) has been associated with other rare but significant
complications including coma and diabetes insipidus. Large deviations in catheter placement
have resulted in catheter insertion into significant brain regions (thalamus, hypothalamus,
basal ganglion, internal capsule. Angular error within the coronal plane is the primary
determinant of successful catheter insertion.
Bullseye is a novel intra-procedural system the investigators initially developed for glenoid
guidepin placement. Bullseye EVD uses a verification workflow (guess and check) to identify
EVD catheter position and trajectory with reference to the diagnostic CT image prior to
catheter insertion using structured-light imaging. Structured-light scanning currently has
several medical applications due to its speed, accuracy, and robust 3D surface
reconstruction, and has been investigated in planning bedside subdural evacuation port system
placement. In vitro performance of Bullseye EVD was demonstrated through testing on 3
cadaveric specimens to localize EVD placement on both sides of each of the heads (N=6 trials
in total). The success of this in vitro work motivated further development of the technology
including clinical evaluation for EVD.
Reducing EVD malpositioning and associated complications is a priority for neurosurgeons,
however costly and cumbersome navigation solutions have had limited uptake in this urgent
procedure that is often conducted at the bedside. Bullseye EVD represents a portable, safe,
low-cost technology that can identify catheter positioning on existing preprocedural CT
imaging. The proposed work, including integration into the existing clinical workflow,
evaluation of in vivo accuracy and automation to enable rapid feedback during EVD placement,
is critical to translating this technology from the bench to the bedside.