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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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

観察的

入学 (推定)

200

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Postoperative Delirium (POD)
時間枠: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
時間枠: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
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Duration of Mechanical Ventilation
時間枠: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
時間枠: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
時間枠: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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア:Jingyuan Xu, MD、Southeast University School of Medicine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月6日

一次修了 (推定)

2027年12月1日

研究の完了 (推定)

2027年12月30日

試験登録日

最初に提出

2026年6月30日

QC基準を満たした最初の提出物

2026年6月30日

最初の投稿 (実際)

2026年7月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月8日

QC基準を満たした最後の更新が送信されました

2026年7月6日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2026ZDSYLL134-P01
  • 82572527 (その他の助成金/資金番号:The National Natural Science Foundations of China)
  • 82272211 (その他の助成金/資金番号:The National Natural Science Foundations of China)
  • BK20252100 (その他の助成金/資金番号:The General Natural Science Foundation of Jiangsu Province)
  • zdyyxy29 (その他の助成金/資金番号:Jiangsu Province High-Level Hospital Pairing Assistance)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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