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| Name | Class |
|---|---|
| NeurOptics Inc | INDUSTRY |
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The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.
Paired assessments will be made on patients who are consented; and on healthy controls who have verbally assented to participate. We plan to enroll 20 patients and 50 healthy controls. Assessments will be made at the convenience of the patient and healthy controls. Each assessment will include bilateral PLR reading within a 5 minute interval. The first assessment will be completed with the NPi-200 and the second assessment will use the NPi-300. The data will be entered into a CRF.
If there is a significant difference between readings from the NPi-200 and the NPi-300, we will repeat the bilateral assessment in the following hour and the regularly scheduled time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with risk of cerebral edema. |
| |
| Healthy Control | Staff/Faculty who interact with patients at the enrolling site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPi-200 and NPi-300 pupillometers | Device | Device which measures PLR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pupil's reaction to light as measured by Neurological Pupil Index (NPI) | Pupil's reaction to light as measured by Neurological Pupil Index (NPI) algorithm using pupillometer device that grades the pupil's reaction to light on a scale between 0 and 5. The Inter-device reliability is assessed using Cohen's Kappa method: values ≤ 0 as indicating no agreement. | 1 year |
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Inclusion Criteria (Patient Cohort):
Exclusion Criteria (Patient Cohort):
Inclusion Criteria (Healthy Control Cohort):
Exclusion Criteria (Healthy Control Cohort):
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Patient Cohort: Patients admitted with a neurological or neurosurgical diagnosis that place them at risk for cerebral edema.
Healthy Cohort: Faculty/Staff who interact with patients at the enrolling site
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| Name | Affiliation | Role |
|---|---|---|
| DaiWai M Olson, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clements University Hospital | Dallas | Texas | 75235 | United States |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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