Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2028-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Neurological Pupil Index (NPi) on Intensive Care Unit (ICU) Trial

NCT01920347

Hypoxic Encephalopathy

COMPLETED

Inter-Device Reliability of the NPi-300 Pupillometer

NCT04993833

Critical Illness Neuropathy

COMPLETED

Interrater Reliability of Subjective Pupillary Assessments

NCT02296606

Interrater Reliability Among Pupillary Assessments

COMPLETED

Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury

NCT02465242

Traumatic Brain Injury

UNKNOWN

Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx

NCT04490005

Acute Brain Injury Pupillary Reflex Impaired

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.