Inter-Device Reliability of the NPi-300 Pupillometer (TRIPLE)

September 27, 2022 updated by: DaiWai Olson, University of Texas Southwestern Medical Center
The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Clements University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with risk of cerebral edema.
Device: NPi-200 and NPi-300 pupillometers
Device which measures PLR.
Healthy Control
Staff/Faculty who interact with patients at the enrolling site.
Device: NPi-200 and NPi-300 pupillometers
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

NeurOptics Inc.

Investigators

  • Principal Investigator: DaiWai M Olson, PhD, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

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

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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.

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