| Registry | NCT02804438, acronym ENDPANIC |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 1000 (Estimated) |
| Sponsor | University of Texas Southwestern Medical Center (Other); collaborators: NeurOptics Inc |
| Conditions | Critical Illness, Neuropathy |
| Dates | start 2015-07-01, primary completion 2028-09-01 (estimated), completion 2028-09-01 (estimated), first posted 2016-06-17, last updated 2026-10-23 |
| Locations | 1 site in United States |
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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.
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.
Sex: All
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
| Facility | City | Country | Status |
|---|---|---|---|
| Maria E Denbow | Dallas, Texas | United States | Recruiting |