Subdural Hematoma
Conditions
Brief summary
This study involves using a augmented reality (AR) system to assist in the placement of a subdural evacuating portal system (SEPS). In the first part of the study, all participants will have skin marking of an AR-guided and non-AR-guided site to determine feasibility and method accuracy. In the second part, subjects will be randomized to AR-guided and non-AR-guided SEPS placement to determine efficacy.
Detailed description
Chronic/subacute subdural hematoma (SDH) is one of the most common diseases encountered in neurosurgical practice. However, there is little consensus on first-line treatment. The SEPS was developed to implement a minimally invasive approach to drainage. New imaging technologies, such as augmented reality (AR) interfaces, can provide anatomical models and can help visualize hidden structures. The hope is that this study can give insight on whether AR-guidance can be used to improve SEPS placement, which can lead to higher volume drainage, greater symptomatic improvement, and decreased hospital stay.
Interventions
DEVICEAugmented Reality Device
AR device will be used to determine where to place SEPS drain
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Unilateral or Bilateral subdural hematoma that is planned to be treated by SEPS
Exclusion criteria
* Unable to have CT scan * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean accuracy (in mm) of SEPS placement | Intra-procedural and up to 24 hours post procedure | Comparison of measurements obtained by standard of care surface measurements and placement using AR guidance, and post placement CT scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in size (mm) of subdural hematoma | Pre-procedure and 24 hours after SEPS placement | Radiographic measure of thickest hematoma volume in sagittal and coronal planes after subdural evacuation compared to pre-procedure imaging, assessed in the randomized AR-guided and non-AR-guided arms only. |
| Change in symptom score | Assess at 24 hours status post SEPS placement and again at 1 month | Composite measure, scaled from 0 (no symptoms) to 10 (severe symptoms), scored by clinician based overall impression of objective and subjective signs and symptoms including neurological strength exam, cognitive status, and patient self-reported symptomatic change, assessed in the randomized AR-guided and non-AR-guided arms only. |
| Length of hospital stay | Approximately 2 to 5 days | Number of days since procedure between SEPS placement and discharge from inpatient stay, assessed in the randomized AR-guided and non-AR-guided arms only. |
Countries
United States
Outcome results
None listed