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临床试验/NCT07686900
NCT07686900尚未招募不适用

A Dynamic Early Warning System for Postoperative Delirium After Cardiac Surgery Integrating EEG, Cerebral Oxygenation, Hemodynamic Physiology, and Clinical Risk Factors

Southeast University, China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
Incidence of Postoperative Delirium (POD)

研究概览

简要总结

After heart surgery, up to half of all patients may develop a state of sudden confusion called postoperative delirium. This condition can lead to longer time on a breathing machine, extended stays in the intensive care unit (ICU), and a slower overall recovery. Currently, doctors have no reliable way to predict delirium early enough to take preventive action. This study aims to build a computer-based early warning system. The system will combine continuous, real-time measurements of brain waves (EEG), the oxygen level in the brain, and heart and blood pressure function. It will also include information about each patient's health status. By analyzing all of these signals together, the model is designed to give an alert 1 to 6 hours before delirium might start, giving the care team a window of time to intervene. The study will take place in the ICU at Zhongda Hospital, Southeast University. Adults between 18 and 80 years old who are admitted to the ICU after heart surgery will be invited to participate. All patients will receive the usual standard of care; the study does not test any new treatment. Participation means the investigators will continuously record the brain, oxygen, and heart signals that are already being monitored, and a researcher will regularly assess the patient's thinking and alertness with a simple bedside check.

详细描述

Postoperative delirium (POD) following cardiac surgery has an incidence of 20-50% and is associated with prolonged mechanical ventilation, extended ICU and hospital stay, and increased mortality. Its pathophysiology involves a complex interplay of cerebral hypoperfusion, neuroinflammation, blood-brain barrier disruption, and neurotransmitter imbalances-a "multiple-hit" model. Current clinical assessment relies on static risk stratification or post-hoc diagnostic tools , which lack the dynamic, pre-symptomatic warning capability needed for timely intervention. The increasing availability of multimodal ICU monitoring (EEG, near-infrared spectroscopy, invasive hemodynamics) and advanced time-series deep learning provides an unprecedented opportunity to capture the evolution of physiological uncoupling before the clinical manifestation of delirium.

Objective: This study aims to develop and validate a multimodal deep learning model that fuses continuous central electrophysiology (frontal EEG), regional cerebral oxygen saturation (rScO₂), macro-hemodynamic parameters, and clinical static/dynamic risk factors to provide a dynamic early warning of POD 1-6 hours in advance.

Study Design: This is a single-center, prospective, observational cohort study. Setting and Population: The study will enroll consecutive adult patients (18-80 years) admitted to the Department of Critical Care Medicine at Zhongda Hospital, Southeast University, after cardiac surgery (CABG, valve repair/replacement, major aortic surgery, or combined procedures) between May 1, 2026 and December 30, 2027. All eligible patients must have multimodal monitoring including continuous EEG, bilateral frontal rScO₂, and invasive arterial blood pressure, and must provide informed consent.

Key Exclusion Criteria: Pre-existing dementia, psychiatric illness or long-term antipsychotic use precluding accurate delirium assessment; severe hepatic (Child-Pugh C) or renal insufficiency (eGFR <30 mL/min/1.73 m²); significant brain injury or seizure history; inability to obtain adequate signal quality; expected death within 24 hours.

Data Collection and Monitoring: Data will be captured at multiple time windows: preoperative baseline, intraoperative period, and postoperative time points (immediately upon ICU arrival, 6h, 24h, 48h, and at the moment delirium is first detected). Preoperative phenotyping includes demographics, MoCA, Clinical Frailty Scale, and EuroSCORE II. Continuous EEG features (power spectral density, burst suppression ratio, complexity indices) and rScO₂ (baseline, desaturation events >20%, autoregulation index COx) will be recorded. Hemodynamic variables include heart rate, beat-to-beat blood pressure variability, and, where available, derived cardiac output metrics. Comprehensive clinical data (laboratory values, sedation/analgesic dosing, vasoactive-inotropic score, mechanical ventilation parameters, and SOFA/APACHE II scores) will be collected concurrently.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (18-80 years) admitted to the Department of Critical Care Medicine.
  • Underwent cardiac surgery.
  • Under multimodal monitoring (including EEG, cerebral oximetry, and invasive arterial blood pressure).
  • Signed informed consent.

排除标准

  • Pre-existing dementia, history of psychiatric disorders, or long-term use of antipsychotic medications, preventing accurate assessment of delirium.
  • Preoperative severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR <30 mL/min/1.73 m²).
  • Severe craniocerebral injury, intracranial space-occupying lesion, or history of epilepsy.
  • Inability to obtain continuous EEG or cerebral oximetry signals due to technical reasons (e.g., scalp injury, abnormal probe placement site).
  • Patients expected to die within 24 hours.
  • Patients deemed unsuitable for the study by the investigator.

研究组 & 干预措施

Cardiac Surgery Patients

Adult patients (18-80 years) admitted to the ICU after cardiac surgery (CABG, valve repair/replacement, major aortic surgery, or combined procedures) who meet all inclusion criteria and provide informed consent. All participants receive standard clinical care without any experimental interventions. They undergo multimodal monitoring (continuous frontal EEG, bilateral rScO₂, invasive arterial blood pressure) and serial delirium assessments (CAM-ICU) according to the study schedule.

结局指标

主要结局

Incidence of Postoperative Delirium (POD)

时间窗: From ICU admission until ICU discharge or Day 7 postoperatively, whichever occurs first.

The proportion of participants who develop postoperative delirium during the ICU stay following cardiac surgery. Delirium is diagnosed using the Confusion Assessment Method for the ICU (CAM-ICU) and classified as positive (delirium present) or negative (no delirium).

Time to Onset of Postoperative Delirium

时间窗: From end of surgery until first documented delirium or ICU discharge, up to 7 days.

The time (in hours) from the end of cardiac surgery (skin closure) to the first positive CAM-ICU assessment. Only for participants who develop POD.

Duration of Postoperative Delirium

时间窗: From first delirium onset until delirium resolution or ICU discharge, up to 7 days.

The total duration (in hours) from the first positive CAM-ICU assessment to the last positive CAM-ICU assessment, with no recurrence within 24 hours.

次要结局

  • Duration of Mechanical Ventilation(From ICU admission until extubation, assessed throughout ICU stay, up to 30 days.)
  • Intensive Care Unit Length of Stay(From ICU admission to ICU discharge, up to 30 days.)
  • Hospital Length of Stay(From hospital admission to hospital discharge, up to 90 days.)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jingyuan,Xu

Associate Professor and Director, Department of Intensive Care Medicine

Southeast University, China

研究点 (1)

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