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Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care (ENDPANIC)

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ClinicalTrials.gov Identifier: NCT02804438
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : August 17, 2020
Sponsor:
Collaborator:
NeurOptics Inc.
Information provided by (Responsible Party):
DaiWai Olson, University of Texas Southwestern Medical Center

Brief Summary:

The purpose of this study is to collect a large amount of data that may assist in addressing the gap in knowledge of understanding pupillometer readings using a pupillometer device.

The aim of this project is to establish normative values for pupillometer data. Measures of central tendency will be developed for the variables provided by automated pupillary exams, which will provide an enhanced understanding of clinically appropriate pupil values for size, reactivity, and neurological pupil index.


Condition or disease
Critical Illness Neuropathy

Detailed Description:
Data will be collected on patients in the intensive care units at the selected hospitals on patients who have been assigned, by the attending physician, to have regular pupillary assessments, and in whom staff nurses are performing pupillary assessments with the pupillometer. While a sample size estimate would be considered inappropriate for registry development, power analysis techniques were used to examine the potential of this registry to generate adequate information to begin to fully describe normative data for pupillary exams. Using the assumption that the desire is to understand neurological pupil index (NPi) and size differences within 0.1, and that the spread of data would be approximately normally distributed, a minimum of 3,250 observations is required (alpha = 0.05, beta = 0.80). It must, however, be repeated that this is simply a rough estimate. The registry data generated will, in fact, be the source of data from which future studies will be powered.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care
Actual Study Start Date : July 2015
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022



Primary Outcome Measures :
  1. Oculomotor evaluation of pupillary variance during ICU admission [ Time Frame: Daily at 9:00am ]
    Pupil size and reactivity per neurological pupil index



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In-patient
Criteria

Inclusion Criteria:

  • Data will be collected on patients admitted to enrolling hospitals who have been assigned, by the attending physician, to have regular pupillary assessments, and in whom staff nurses are performing pupillary assessments with the pupillometer.

Exclusion Criteria:

  • Out-patients
  • Patients that do not have orders for regular pupillary assessments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804438


Contacts
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Contact: DaiWai M Olson, PhD 214-648-8946 DaiWai.Olson@UTSouthwestern.edu
Contact: Sonja Stutzman, PhD 214-648-6719 Sonja.Stutzman@UTSouthwestern.edu

Locations
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United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Sonja Stutzman, PhD    214-648-6719    Sonja.Stutzman@UTSouthwestern.edu   
Contact: DaiWai Olson, PhD    214-648-8946    DaiWai.Olson@UTSouthwestern.edu   
Principal Investigator: DaiWai Olson, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
NeurOptics Inc.
Additional Information:

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Responsible Party: DaiWai Olson, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02804438    
Other Study ID Numbers: STU 062015-005
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes