Interrater Reliability of Subjective Pupillary Assessments
December 19, 2017 updated by: DaiWai Olson, University of Texas Southwestern Medical Center
Prospective, observational, non-randomized study of interrater reliability of pupillary assessments, comparing two clinical assessments to the Pupillometer.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
127
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
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients eligible for the study are those that have been diagnosed some form of brain trauma where brain swelling has been identified and pupil dilation has been incorporated into standard of care (e.g., TBI, stroke).
Description
Inclusion Criteria:
- Patients are eligible for this study if they have been diagnosed with some form of brain trauma (e.g., stroke, traumatic brain injury, aneurysm)
Exclusion Criteria:
- Prisoners
- Under 18 years of age
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. Explore the Interrater Reliability of Pupillary Assessments When Conducted in the Natural Setting by a Diverse Group of Practitioners
Time Frame: 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.
|
9 months of pupillary assessments
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
November 18, 2014
First Submitted That Met QC Criteria
November 19, 2014
First Posted (Estimate)
November 20, 2014
Study Record Updates
Last Update Posted (Actual)
January 19, 2018
Last Update Submitted That Met QC Criteria
December 19, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- STU042014-043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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