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

ICU Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187792
• Other study ID #: 202306099DINA
• Status: Recruiting
• Start date: October 4, 2023
• Est. completion date: September 2025

Study information

• Verified date: October 2023
• Source: National Taiwan University Hospital
• Contact: Ming-Chen Chiang
• Phone: (886) 02-23123456
• Email: jane.c0203[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• ICU Delirium

Locations

Country	Name	City	State
Taiwan	Ming-Chen Chiang	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constructing a model based on pupillary parameters and delirium:	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