The Cooper Health System
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?
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 prot…
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.
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.
Arctuva estimate
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