Inter-Device Reliability of the NPi-300 Pupillometer (TRIPLE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75235
- Clements University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Description
Inclusion Criteria (Patient Cohort):
- 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.
Exclusion Criteria (Patient Cohort):
- Patients that will be excluded from the study are those that are prisoners, under 18 years of age, or pregnant women.
Inclusion Criteria (Healthy Control Cohort):
- Staff in the enrolling site
Exclusion Criteria (Healthy Control Cohort):
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
Patients with risk of cerebral edema.
|
Device which measures PLR.
|
|
Healthy Control
Staff/Faculty who interact with patients at the enrolling site.
|
Device which measures PLR.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pupil's reaction to light as measured by Neurological Pupil Index (NPI)
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: DaiWai M Olson, PhD, University of Texas Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2021-0693
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.