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

Sponsor
Ruijin Hospital
Study ID
NCT07337356
Status
Not Yet Recruiting

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Conditions

  • Delirium
  • Machine Learning
  • Prediction Models

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jan 13, 2026
Start date
Feb 1, 2026
Status verified
Dec 2025
Primary completion
Sep 1, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
795 participants (estimated)

Arms

  • Arm: 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;
  • Arm: 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).

Primary Outcome Measure

Number of participants with delirium as assessed by DSM-5 [ Time Frame: 7th day after ICU admission ]

Central Contacts

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