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Prospective, observational, non-randomized study of interrater reliability of pupillary assessments, comparing two clinical assessments to the Pupillometer.
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| Measure | Description | Time Frame |
|---|---|---|
| 1. Explore the Interrater Reliability of Pupillary Assessments When Conducted in the Natural Setting by a Diverse Group of Practitioners | Two human assessors conducted and recorded the results of a clinical pupillary assessment on one patient within 5 minutes of one another. The researcher then conducted and recorded pupillary information on the same patient (within the same 5 minute window) using the NeurOptics Pupillometer. | 9 months of pupillary assessments |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible for the study are those that have been diagnosed some form of brain trauma where brain swelling has been identified and pupil dilation has been incorporated into standard of care (e.g., TBI, stroke).
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants underwent three pupil exams, two by flashlight/pen light by two different assessors, and one by a researcher using the Pupillometer Device. Pupil exams occurred up to three times daily for the extent that the patient was in the ICU at the enrolling hospital. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 1. Explore the Interrater Reliability of Pupillary Assessments When Conducted in the Natural Setting by a Diverse Group of Practitioners | Two human assessors conducted and recorded the results of a clinical pupillary assessment on one patient within 5 minutes of one another. The researcher then conducted and recorded pupillary information on the same patient (within the same 5 minute window) using the NeurOptics Pupillometer. | Posted | Mean | 95% Confidence Interval | Kappa score | 9 months of pupillary assessments | paired pupil assessments | paired pupil assessments |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | There are no groups/arms for the purpose of this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DaiWai Olson | The University of Texas Southwestern Medical Center | 214-648-8946 | Daiwai.Olson@UTSouthwestern.edu |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| paired pupil assessments |
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| 0 |
| 127 |
| 0 |
| 127 |
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