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

N/ANot Yet RecruitingNCT07042048

The Cooper Health System50 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

ICH - Intracerebral Hemorrhage IVH- Intraventricular Hemorrhage TBI Traumatic Brain Injury

Interventions

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.

EVD placement - AR assistedDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Successful EVD catheter placement

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.

Time frame: During procedure

rate of complication during placement

Time frame: During procedure

Secondary Outcomes

rate of catheter tip dispositions

Time frame: During procedure

number of passes for placement

Time frame: During procedure

rate of AR or Stealth overlay failures on first try

Time frame: During procedure

rate of EVD failure

Time frame: from placement to removal of EVD and assessed up to two weeks after

EVD dislodgment of occlusion

Time frame: from placement to removal of EVD and assessed up to two weeks after

rate of EVD replacement or revision

Time frame: During procedure

rate of EVD associated hemorrhage

Time frame: from placement to removal of EVD and assessed up to two weeks after

rate if EVD-associated infection

Time frame: from placement to removal of EVD and assessed up to two weeks after

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts