Inter-Device Reliability of the NPi-300 Pupillometer

Critical Illness Clinical Trial

— TRIPLE  

Official title:

Inter-Device Reliability of the NPi-300 Pupillometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993833
• Other study ID #: STU-2021-0693
• Status: Completed
• Start date: August 25, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: September 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to explore the inter-device reliability between the NPi-200 and NPi-300.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Neuropathy

Intervention

Device:
• NPi-200 and NPi-300 pupillometers
Device which measures PLR.

Locations

Country	Name	City	State
United States	Clements University Hospital	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	NeurOptics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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