Interrater Reliability Among Pupillary AssessmentsNCT02296606
Interrater Reliability of Subjective Pupillary Assessments
An observational study of Interrater Reliability Among Pupillary Assessments, run by University of Texas Southwestern Medical Center.
Trial summary
Prospective, observational, non-randomized study of interrater reliability of pupillary assessments, comparing two clinical assessments to the Pupillometer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interrater Reliability Among Pupillary Assessments
- How many people
- 127 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients are eligible for this study if they have been diagnosed with some form of brain trauma (e.g., stroke, traumatic brain injury, aneurysm)
Who cannot join
- Prisoners
- Under 18 years of age
About this study
Prospective, observational, non-randomized study of interrater reliability of pupillary assessments, comparing two clinical assessments to the Pupillometer.
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Explore the Interrater Reliability of Pupillary Assessments When Conducted in the Natural Setting by a Diverse Group of Practitioners
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.
Measured: 9 months of pupillary assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Interrater Reliability Among Pupillary AssessmentsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DaiWai Olson, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296606
- Sponsor's protocol ID
- STU042014-043
- Status last verified
- Dec 2017
- First submitted
- 18 Nov 2014
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrater Reliability of Subjective Pupillary Assessments
- ClinicalTrials.gov ID
- NCT02296606
- Acronym / sponsor ID
- STU042014-043
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Posted 15 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, observational, non-randomized study of interrater reliability of pupillary assessments, comparing two clinical assessments to the Pupillometer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients are eligible for this study if they have been diagnosed with some form of brain trauma (e.g., stroke, traumatic brain injury, aneurysm)
Key exclusion criteria (2 listed)
- Prisoners
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Interrater Reliability Among Pupillary Assessments, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2018.