Research on the Development and Validation of an Early Prediction Model for Delirium

NCT ID: NCT07337356

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 795 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-02-01

Brief Summary

Delirium has a high incidence rate and significantly affects patient prognosis. Diagnosis often relies on manual assessment, which is subject to strong subjectivity, high rates of missed diagnosis, and poor stability. This study employs non-contact identification technology based on machine vision analysis to quantitatively analyze characteristic biological feature data such as micro-expressions. It then investigates the correlation between these features and delirium subtypes. By integrating clinical phenotypic data and using machine learning algorithms, a multi-modal early prediction model for delirium is constructed to meet the clinical need for early warning of delirium subtypes and enhance the efficacy of delirium identification.

Conditions

Delirium; Prediction Models; Machine Learning

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

observational

1. Meets the delirium diagnostic criteria specified in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), which requires the concurrent presence of: ① disturbance in awareness (reduced clarity of awareness of the environment) ; ② change in cognition (e.g., memory impairment, disorientation);

2. Undergoes consecutive daily assessments for 7 days using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) at three time points (8:00, 14:00, 20:00) with an interval of ≥ 6 hours between each assessment, with at least two positive results;

No interventions assigned to this group

control

Admitted to the ICU during the same period, with negative results on consecutive daily CAM-ICU assessments for 3 days (three assessments per day as the observational group).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years, expected ICU stay ≥ 24 hours, and informed consent to participate in this study;

Exclusion Criteria

• Patients with severe facial trauma/deformities that prevent complete expression acquisition, and patients with a history of emotional problems (such as anxiety, depression, etc.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

weiqing Zhang Ph.D, Ph.D

Role: CONTACT

weiq.zh@163.com

8618521525300

Other Identifiers

ZWQ21886-2025-EC-579

Identifier Type: -

Identifier Source: org_study_id