Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/9/2018 |
| Start Date: | July 2015 |
| End Date: | June 2019 |
| Contact: | DaiWai M Olson, PhD |
| Email: | DaiWai.Olson@UTSouthwestern.edu |
| Phone: | 214-648-8946 |
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.
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.
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.
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
We found this trial at
1
site
1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: DaiWai Olson, PhD
Phone: 214-648-6719
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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