Inter-Device Reliability of the NPi-300 Pupillometer
TRIPLE
1 other identifier
observational
70
1 country
1
Brief Summary
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedStudy Start
First participant enrolled
August 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedSeptember 30, 2022
September 1, 2022
1 year
July 13, 2021
September 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Patients
Patients with risk of cerebral edema.
Healthy Control
Staff/Faculty who interact with patients at the enrolling site.
Interventions
Eligibility Criteria
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
You may qualify if:
- Subjects will be included if they are adults (\>18 years of age) and have a neurological or neurosurgical diagnosis that place them at risk for cerebral edema. Subjects also have to be admitted to the enrolling site. Persons consenting for the study (whether patient or LAR) will need to be able to consent for the study in English.
You may not qualify if:
- Patients that will be excluded from the study are those that are prisoners, under 18 years of age, or pregnant women.
- Staff in the enrolling site
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Texas Southwestern Medical Centerlead
- NeurOptics Inc.collaborator
Study Sites (1)
Clements University Hospital
Dallas, Texas, 75235, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
DaiWai M Olson, PhD
University of Texas Southwestern Medical Center
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Neuroscience Nursing Research Center
Study Record Dates
First Submitted
July 13, 2021
First Posted
August 6, 2021
Study Start
August 25, 2021
Primary Completion
August 31, 2022
Study Completion
August 31, 2022
Last Updated
September 30, 2022
Record last verified: 2022-09