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Dynamic Multimodal Delirium Warning After Cardiac Surgery (DEW-POD)

2026年7月6日 更新者:Jingyuan,Xu、Southeast University, China

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

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.

研究概览

地位

尚未招聘

详细说明

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.

Delirium Assessment: Trained research staff will assess delirium using the Confusion Assessment Method for the ICU (CAM-ICU) in conjunction with the Richmond Agitation-Sedation Scale (RASS). Assessments occur at baseline, postoperatively when the patient is awake, and at scheduled intervals, with documentation of first onset, duration, and subtype (hyperactive, hypoactive, mixed).

Model Development and Analysis: All signals will be time-aligned to construct a high-resolution multimodal time-series dataset. The primary predictive model will be based on a Transformer or Long Short-Term Memory (LSTM) architecture employing a sliding window approach (e.g., input: preceding 2 hours; output: predicted delirium risk in the next 1-6 hours). The dataset will be split into training, validation, and test sets (7:1.5:1.5). Primary performance metrics are area under the receiver operating characteristic curve (AUC), sensitivity, specificity, positive/negative predictive values, and the achievable warning lead time. Model interpretability will be explored using SHAP or attention weight analysis. The added value of multimodal fusion will be quantified by comparing the full model against unimodal baselines (clinical data only, EEG only, or rScO₂ only).

Outcomes: The primary outcome is the occurrence of POD. Secondary outcomes include duration of mechanical ventilation, ICU length of stay, and hospital length of stay.

Significance: By delineating the temporal trajectories of EEG, cerebral oxygenation, and systemic hemodynamics preceding delirium, this study will provide new pathophysiological insights into the "cerebral perfusion-metabolism-electrical activity" uncoupling hypothesis and deliver a clinically implementable early warning framework to enable proactive brain-directed interventions.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

The study population consists of adult patients after cardiac surgery admitted to the Department of Critical Care Medicine, Zhongda Hospital, Southeast University, from May 1, 2026 to December 30, 2027.

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of Postoperative Delirium (POD)
大体时间: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).
From ICU admission until ICU discharge or Day 7 postoperatively, whichever occurs first.
Time to Onset of Postoperative Delirium
大体时间: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.
From end of surgery until first documented delirium or ICU discharge, up to 7 days.
Duration of Postoperative Delirium
大体时间: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.
From first delirium onset until delirium resolution or ICU discharge, up to 7 days.

次要结果测量

结果测量
措施说明
大体时间
Duration of Mechanical Ventilation
大体时间:From ICU admission until extubation, assessed throughout ICU stay, up to 30 days.
Total time (in hours) from endotracheal intubation to successful extubation (or removal of ventilatory support) during the index ICU stay.
From ICU admission until extubation, assessed throughout ICU stay, up to 30 days.
Intensive Care Unit Length of Stay
大体时间:From ICU admission to ICU discharge, up to 30 days.
Total number of days spent in the ICU from the date of ICU admission to the date of ICU discharge.
From ICU admission to ICU discharge, up to 30 days.
Hospital Length of Stay
大体时间:From hospital admission to hospital discharge, up to 90 days.
Total number of days from hospital admission (for cardiac surgery) to hospital discharge.
From hospital admission to hospital discharge, up to 90 days.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Jingyuan Xu, MD、Southeast University School of Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月6日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月8日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2026ZDSYLL134-P01
  • 82572527 (其他赠款/资助编号:The National Natural Science Foundations of China)
  • 82272211 (其他赠款/资助编号:The National Natural Science Foundations of China)
  • BK20252100 (其他赠款/资助编号:The General Natural Science Foundation of Jiangsu Province)
  • zdyyxy29 (其他赠款/资助编号:Jiangsu Province High-Level Hospital Pairing Assistance)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

This is an exploratory single-center observational study. A formal individual participant data (IPD) sharing plan has not been established. De-identified data may be made available upon reasonable request to the corresponding author after publication, subject to institutional review board approval and a data use agreement.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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