Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

Critical Illness Clinical Trial

— ENDPANIC  

Official title:

Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804438
• Other study ID #: STU 062015-005
• Status: Recruiting
• Start date: July 2015
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: University of Texas Southwestern Medical Center
• Contact: DaiWai M Olson, PhD
• Phone: 214-648-8946
• Email: DaiWai.Olson[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Neuropathy

Locations

Country	Name	City	State
United States	Maria E Denbow	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	NeurOptics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oculomotor evaluation of pupillary variance during ICU admission	Pupil size and reactivity per neurological pupil index	Daily at 9:00am