Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization

Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization: A Randomized Controlled Clinical Trial (PEARL)

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 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