NCT07536854

Early Delirium Prediction Via Serial EEG Trajectories and Machine Learning

Longitudinal Frontal EEG Trajectories Reveal Divergent Cortical Dynamics in Delirium After Severe Trauma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to develop a machine learning model that can predict delirium in trauma patients before it clinically appears. The study focuses on analyzing brainwave (EEG) patterns collected over several days in the trauma ICU. By comparing different recording conditions-such as having eyes open versus closed-researchers aim to identify the most effective way to monitor brain health and detect early signs of delirium in critically ill patients.

Detailed description

Background and Rationale: Delirium is a critical manifestation of acute brain dysfunction, affecting 10-15% of all hospitalized patients and over 25% of those in intensive care units (ICU). In the trauma ICU, patients are particularly vulnerable due to an inflammatory cascade from repeated surgeries, blood-brain barrier disruption, traumatic brain injury (TBI), and mandatory opioid administration. Despite its clinical significance-including increased mortality and long-term cognitive impairment-early detection remains challenging. Current bedside tools like the CAM-ICU are limited by their periodic nature and dependence on clinician expertise, often missing the rapid neurophysiologic fluctuations that define delirium. Study Objectives and Methodology: While previous studies have used electroencephalography (EEG) as a "snapshot" to identify delirium, such cross-sectional approaches often reflect transient sedative depth rather than true neurocognitive vulnerability. This study proposes a longitudinal approach, focusing on the trajectory of change in cortical dynamics over time. We acquired brief, serial resting-state EEG three times daily for at least three consecutive days from critically ill trauma patients. Using a feasible frontal montage, we quantified a comprehensive set of features, including spectral power (slowing), nonlinear complexity, and phase-based functional connectivity. Research Hypothesis: The framework utilizes machine learning (ML) to harness these longitudinal trajectories, aiming to predict delirium vulnerability before formal clinical diagnosis. Furthermore, we hypothesize that eyes-open recordings-by imposing a minimal arousal constraint-will better capture wakeful network integrity and provide superior predictive power compared to traditional eyes-closed recordings, which are often confounded by sedation and drowsiness in the trauma ICU environment. Clinical Impact: By identifying the optimal recording condition and establishing an ML-based prediction framework, this study seeks to define a standardized neurophysiologic monitoring strategy. This will ultimately facilitate early intervention and improve the long-term neurological prognosis of severe trauma survivors.

Conditions

• Delirium
• Trauma
• Brain Dysfunction
• Critical Illness

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-04-27
• Completion: 2025-04-30
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: South Korea