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

Research on the Development and Validation of an Early Prediction Model for Delirium Based on Machine Vision Analysis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium; Machine Learning; Prediction Models

• Study Type: Observational
• Enrollment (Estimated): 795

Contacts and Locations

• Study Contact: Name: weiqing Zhang Ph.D, Ph.D; Phone Number: 8618521525300; Email: weiq.zh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) admitted to the ICU of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, including elderly patients, those post-surgery, with sepsis, and trauma, which are common high-risk populations for delirium.

Description

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.).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
observational; 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);; 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;
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with delirium as assessed by DSM-5	Zero is equivalent to no delirium and a high score means a higher occurrence of delirium	7th day after ICU admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	Zero is equivalent to the minimum accuracy, while a value of 1 represents perfect accuracy	7th day after ICU admission
Precision	The proportion of truly positive samples among those predicted as positive; the closer the score is to 1, the higher the precision	7th day after ICU admission
Recall	The proportion of truly positive samples that are correctly predicted; the closer the score is to 1, the higher the diagnostic sensitivity	7th day after ICU admission
F1-score	The harmonic mean of precision and recall; the higher the score, the better the diagnostic performance of the model	7th day after ICU admission

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium
• Other Study ID Numbers: ZWQ21886-2025-EC-579

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