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Interrater Reliability of Subjective Pupillary Assessments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02296606
Recruitment Status : Completed
First Posted : November 20, 2014
Results First Posted : December 15, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
DaiWai Olson, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
Prospective, observational, non-randomized study of interrater reliability of pupillary assessments, comparing two clinical assessments to the Pupillometer.

Condition or disease
Interrater Reliability Among Pupillary Assessments

Study Design
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Study Type : Observational
Actual Enrollment : 127 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2014

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MedlinePlus related topics: Health Checkup

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: DaiWai Olson, Associate Faculty, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02296606    
Other Study ID Numbers: STU042014-043
First Posted: November 20, 2014    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: January 19, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No