ICH - Intracerebral Hemorrhage, IVH- Intraventricular Hemorrhage, TBI Traumatic Brain Injury
Conditions
Keywords
EVD, Augmented Reality, TBI, ICH, Image Guidance
Brief summary
The goal of this clinical trial is to assess if EVD placement using augmented reality is non inferior to image-guidance systems for assistance in adult patients needing an EVD for spontaneous ICH with IVH or severe TBI. The main question it aims to answer is: Can EVDs be placed successfully with at least equal safety and efficacy using augmented reality devices in comparison to using standard image-guidance techniques?
Interventions
DEVICEEVD placement - image-guidance assisted
During EVD placement, an image-guided noninvasive systems will be used to assist the operator for EVD catheter tip navigation through a burr hole opening. The use of image-guidance system occurs once during initial EVD placement in this trial.
DEVICEEVD placement - AR assisted
During EVD placement, an AR system will be used to assist the operator for EVD catheter tip navigation through a burr hole opening. The use of AR occurs once during initial EVD placement in this trial.
Sponsors
The Cooper Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patient at time of screening * diagnosis of spontaneous ICH with IVH with severe TBI * Meet one or more of the following clinical or radiographic criteria: Tissue swelling on imaging Dysmorphic ventricles on imaging Midline shift \>2mm on imaging Mass effect on imaging Evans Index \<0.3 on imaging Glasgow Coma Scale 3-8 * admitted to Cooper University Health * requires an EVD
Exclusion criteria
* Other concomitant intracranial pathology (e.g., tumor, tumor-related edema/hemorrhage, congenital condition, etc.) * Concurrent participation in another research protocol for investigation of an experimental therapy * Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful EVD catheter placement | During procedure | Post-procedural non-contrast head CT will be reviewed by masked assessor to evaluate success of EVD placement per the Kakarla grading system. This grading system classifies catheter positioning into three grades based on postoperative imaging. Grade 1 indicates optimal placement in the ipsilateral frontal horn or third ventricle for effective drainage. Grade 2 represents functional but non-ideal placement in the contralateral ventricle or non-eloquent cortex. Grade 3 denotes suboptimal placement in eloquent cortex or non-target spaces, potentially leading to complications. Thus, a higher score means a worse outcome. |
| rate of complication during placement | During procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of AR or Stealth overlay failures on first try | During procedure |
| rate of EVD failure | from placement to removal of EVD and assessed up to two weeks after |
| EVD dislodgment of occlusion | from placement to removal of EVD and assessed up to two weeks after |
| rate of catheter tip dispositions | During procedure |
| rate of EVD associated hemorrhage | from placement to removal of EVD and assessed up to two weeks after |
| rate if EVD-associated infection | from placement to removal of EVD and assessed up to two weeks after |
| rate of EVD replacement or revision | During procedure |
| number of passes for placement | During procedure |
Countries
United States
Contacts
Primary ContactCorey Mossop, MD
Outcome results
None listed