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Recruiting NCT02804438

Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

— Observational Critical Illness Neuropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Critical Illness, Neuropathy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Oculomotor evaluation of pupillary variance during ICU admission [Time frame: Daily at 9:00am]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Maria E Denbow — Dallas

Publications

  • Doyle BR, Aiyagari V, Yokobori S, Kuramatsu JB, Barnes A, Puccio A, Nairon EB, Marshall JL, Olson DM. Anisocoria After Direct Light Stimulus is Associated with Poor Outcomes Following Acute Brain Injury. Neurocrit Care. 2024 Dec;41(3):1020-1026. doi: 10.1007/s12028-024-02030-1. Epub 2024 Jun 25. PMID 38918339
  • 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. PMID 35869429
  • 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. PMID 35776519
  • 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. PMID 33347373

Identifiers

NCT: NCT02804438 · STU 062015-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗