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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented Reality Assistance | Experimental | Placement of EVDs using augmented reality device |
|
| Stealth Image-guided assistance | Active Comparator | Placement of EVDs using Stealth image-guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVD placement - image-guidance assisted | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure |
| rate of complication during placement | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| rate of catheter tip dispositions | During procedure | |
| number of passes for placement | During procedure | |
| rate of AR or Stealth overlay failures on first try |
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Inclusion 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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corey Mossop, MD | Contact | 856-342-2000 | mossop-corey@cooperhealth.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Health | Camden | New Jersey | 08103 | United States |
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|
| EVD placement - AR assisted | Device | 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. |
|
| 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 EVD replacement or revision | 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 |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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