ICCA-Based ICU Physiological State Space Monitor

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Composite Clinical Deterioration Within 72 Hours — Within 72 hours following each eligible index patient-day
  A binary composite outcome defined by the occurrence of at least one of the following events during the 72-hour window after an eligible index patient-day: ICU death; new initiation of invasive mechanical ventilation; new initiation of continuous renal replacement therapy (CRRT); new initiation of extracorporeal membrane oxygenation (ECMO); or a prespecified significant escalation in vasoactive medication support. A participant/index window meeting more than one component will be counted once for the composite outcome.

Trial sites (1)

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