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Trial Outcomes & Findings for Interrater Reliability of Subjective Pupillary Assessments (NCT NCT02296606)

NCT ID: NCT02296606

Last Updated: 2018-01-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

127 participants

Primary outcome timeframe

9 months of pupillary assessments

Results posted on

2018-01-19

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
127
Overall Study
COMPLETED
127
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interrater Reliability of Subjective Pupillary Assessments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=127 Participants
Age, Continuous
55.1 years
STANDARD_DEVIATION 15.6 • n=5 Participants
Sex: Female, Male
Female
55 Participants
n=5 Participants
Sex: Female, Male
Male
72 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
21 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
106 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
12 Participants
n=5 Participants
Race (NIH/OMB)
White
103 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
12 Participants
n=5 Participants
Region of Enrollment
United States
127 participants
n=5 Participants

PRIMARY outcome

Timeframe: 9 months of pupillary assessments

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.

Outcome measures

Outcome measures
Measure
All Participants
n=2329 paired pupil assessments
There are no groups/arms for the purpose of this study.
1. Explore the Interrater Reliability of Pupillary Assessments When Conducted in the Natural Setting by a Diverse Group of Practitioners
.54 Kappa score
Interval 0.5 to 0.57

Adverse Events

All Participants

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

DaiWai Olson

The University of Texas Southwestern Medical Center

Phone: 214-648-8946

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place