Clinical trial NCT02804438: Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care
Official title: Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Neuropathy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: NeurOptics Inc.
First posted: 2016-06-17
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In-patient

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.

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.

Eligibility 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

Primary outcomes:
measure: Oculomotor evaluation of pupillary variance during ICU admission
timeFrame: Daily at 9:00am
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Maria E Denbow
state: Texas
Study officials:
References:
citation: Privitera CM, Neerukonda SV, Aiyagari V, Yokobori S, Puccio AM, Schneider NJ, Stutzman SE, Olson DM; END PANIC Investigators. A differential of the left eye and right eye neurological pupil index is associated with discharge modified Rankin scores in neurologically injured patients. BMC Neurol. 2022 Jul 22;22(1):273. doi: 10.1186/s12883-022-02801-3.
citation: Campos YA, Rana P, Reyes RG, Mazhar K, Stutzman SE, Atem F, Olson DM, Aiyagari V. Relationship Between Automated Pupillometry Measurements and Ventricular Volume in Patients With Aneurysmal Subarachnoid Hemorrhage. J Neurosci Nurs. 2022 Aug 1;54(4):166-170. doi: 10.1097/JNN.0000000000000657. Epub 2022 Jun 21.
citation: Thakur B, Nadim H, Atem F, Stutzman SE, Olson DM. Dilation velocity is associated with Glasgow Coma Scale scores in patients with brain injury. Brain Inj. 2021 Jan 5;35(1):114-118. doi: 10.1080/02699052.2020.1861481. Epub 2020 Dec 21.