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NCT07773571

ICCA-Based ICU Physiological State Space Monitor

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

Critically ill patients can deteriorate rapidly across multiple organ systems. Most intensive care unit (ICU) risk tools rely on measurements collected at a single time point and may not fully capture how physiology evolves or how quickly a patient recovers from disturbance. This single-center retrospective observational study will use routinely collected data from the ICCA reporting database at Zhongshan Hospital, Fudan University to develop and internally validate a research prototype called the ICU Physiological State Space Monitor. Adult ICU admissions will be represented as daily state vectors across 10 physiological domains. The study will characterize each patient's position and movement in a multidimensional state space, identify high-risk regions and possible critical transitions, and quantify physiological resilience using trajectory features such as variability, autocorrelation, curvature, recovery slope, and cross-domain coupling. The primary validation outcome is a composite clinical deterioration event within 72 hours after an eligible index patient-day. The monitor is an analytic and visualization framework for retrospective research and will not be deployed for real-time clinical decision-making in this study.

Official title: Development of an ICU Physiological State Space Monitor Based on the ICCA Database: A Single-Center Retrospective Observational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60000

Start Date

2026-06-15

Completion Date

2029-12-31

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

OTHER

Multidimensional ICU Physiological State and Trajectory Features

The exposure of interest is the participant's multidimensional physiological state and trajectory derived from routinely collected ICU monitoring, laboratory, fluid, medication, organ-support, diagnostic, and demographic data. Daily state vectors will cover 10 physiological domains. Enhanced trajectory features will include state position, displacement, trajectory length, speed, acceleration, turning angle, curvature, local variability, lag-1 autocorrelation, recovery slope, and cross-domain coupling. The investigators will not assign any exposure, treatment, or clinical intervention.

Locations (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, China