Constructing a Model of Pupillary Parameters in Predicting Delirium Among Critically Ill Patients in the Intensive Unit

December 17, 2023 updated by: National Taiwan University Hospital
Delirium is commonly observed in critically ill patients in intensive care units (ICUs), imposing significant burdens on both patients and the healthcare system. Existing assessment tools have certain limitations. Studies have indicated a correlation between pupil parameters and neurological disorders including delirium. Automated Infrared Pupillometry, widely used in neurological disorders, is employed in this study to assess its accuracy and predictive power in evaluating delirium among critically ill patients. The aim is to investigate the accuracy and predictive capability of these parameters in assessing delirium, while identifying the optimal cut-off points. The research findings will contribute to enhancing early detection and prevention of delirium in ICU settings.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Delirium is an acute impairment of attention and cognitive function commonly observed in critically ill patients in intensive care units (ICUs). It leads to long-term cognitive impairment and increased risk of mortality for patients, while also causing distress for healthcare providers and family members, imposing substantial burdens on patients, families, and healthcare systems. Although there are assessment tools and predictive models available for detecting delirium, they have certain limitations.

Recent studies have indicated an association between delirium and the neurotransmitter acetylcholine (ACh). Acetylcholine not only regulates consciousness and cognitive wakefulness but also modulates pupil constriction and light reflex. In clinical practice, the Automated Infrared Pupillometry (AIP) has emerged as a robust tool for assessing acetylcholine, aiding in early delirium detection. However, more research is needed to clearly establish their relationship. This study aims to investigate the accuracy and predictive power of Automated Infrared Pupillometry in assessing delirium among critically ill patients. It involves collecting pupil parameters from critically ill patients and examining the correlation between delirium and pupil parameters using the Intensive Care Delirium Screening Checklist (ICDSC). The goal is to explore the accuracy and predictive capability of these parameters in evaluating delirium, identifying optimal cut-off points. The findings will contribute to enhancing early detection and prevention of delirium in intensive care settings.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 220
        • Recruiting
        • Ming-Chen Chiang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the intensive care unit from internal and surgical departments.

Description

Inclusion Criteria:

  • Patients admitted to the intensive care unit from internal and surgical departments.
  • Ages 18 and above.

Exclusion Criteria:

  • Acute brain injury (hemorrhagic, ischemic stroke).
  • Other brain-related diseases (brain tumor, brain infection, oculomotor nerve paralysis, etc.).
  • Ophthalmic diseases that prevent monitoring of pupil measurements.
  • Patients with pre-hospital cardiac arrest or in-hospital cardiac arrest.
  • Estimated stay in the intensive care unit not exceeding 72 hours.
  • Refusal to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Constructing a model based on pupillary parameters and delirium:
Time Frame: 2023/09/1-2025/08/30
By analyzing the relationship between pupillary parameters and delirium, identifying the optimal cut-off point, and constructing a formula.
2023/09/1-2025/08/30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

December 17, 2023

First Submitted That Met QC Criteria

December 17, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202306099DINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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