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- Sperimentazione clinica NCT07686900
Dynamic Multimodal Delirium Warning After Cardiac Surgery (DEW-POD)
A Dynamic Early Warning System for Postoperative Delirium After Cardiac Surgery Integrating EEG, Cerebral Oxygenation, Hemodynamic Physiology, and Clinical Risk Factors
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Jingyuan Xu, MD
- Numero di telefono: +8613851417209
- Email: xujingyuanmail@163.com
Backup dei contatti dello studio
- Nome: Wanting Lin, MD
- Numero di telefono: 13523253700
- Email: linwanting2022@126.com
Luoghi di studio
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Jiangsu
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Nanjing, Jiangsu, Cina
- Zhongda Hospital Southeast University
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Contatto:
- Jingyuan Xu, MD
- Numero di telefono: +8613851417209
- Email: xujingyuanmail@163.com
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Contatto:
- Email: xujingyuanmail@163.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Incidence of Postoperative Delirium (POD)
Lasso di tempo: From ICU admission until ICU discharge or Day 7 postoperatively, whichever occurs first.
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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).
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From ICU admission until ICU discharge or Day 7 postoperatively, whichever occurs first.
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Time to Onset of Postoperative Delirium
Lasso di tempo: From end of surgery until first documented delirium or ICU discharge, up to 7 days.
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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.
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From end of surgery until first documented delirium or ICU discharge, up to 7 days.
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Duration of Postoperative Delirium
Lasso di tempo: From first delirium onset until delirium resolution or ICU discharge, up to 7 days.
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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.
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From first delirium onset until delirium resolution or ICU discharge, up to 7 days.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Duration of Mechanical Ventilation
Lasso di tempo: From ICU admission until extubation, assessed throughout ICU stay, up to 30 days.
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Total time (in hours) from endotracheal intubation to successful extubation (or removal of ventilatory support) during the index ICU stay.
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From ICU admission until extubation, assessed throughout ICU stay, up to 30 days.
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Intensive Care Unit Length of Stay
Lasso di tempo: From ICU admission to ICU discharge, up to 30 days.
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Total number of days spent in the ICU from the date of ICU admission to the date of ICU discharge.
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From ICU admission to ICU discharge, up to 30 days.
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Hospital Length of Stay
Lasso di tempo: From hospital admission to hospital discharge, up to 90 days.
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Total number of days from hospital admission (for cardiac surgery) to hospital discharge.
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From hospital admission to hospital discharge, up to 90 days.
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Jingyuan Xu, MD, Southeast University School of Medicine
Pubblicazioni e link utili
Pubblicazioni generali
- Saczynski JS, Marcantonio ER, Quach L, Fong TG, Gross A, Inouye SK, Jones RN. Cognitive trajectories after postoperative delirium. N Engl J Med. 2012 Jul 5;367(1):30-9. doi: 10.1056/NEJMoa1112923.
- Lei L, Katznelson R, Fedorko L, Carroll J, Poonawala H, Machina M, Styra R, Rao V, Djaiani G. Cerebral oximetry and postoperative delirium after cardiac surgery: a randomised, controlled trial. Anaesthesia. 2017 Dec;72(12):1456-1466. doi: 10.1111/anae.14056. Epub 2017 Sep 22.
- Bickel H, Gradinger R, Kochs E, Forstl H. High risk of cognitive and functional decline after postoperative delirium. A three-year prospective study. Dement Geriatr Cogn Disord. 2008;26(1):26-31. doi: 10.1159/000140804. Epub 2008 Jun 24.
- Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
- Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
- Wiredu K, Sun H, Boncompte G, Westover MB, Pedemonte JC, Akeju O. The Predictive Power of Intraoperative EEG and Clinical Characteristics for Postoperative Delirium Following Cardiac Surgery. J Clin Neurophysiol. 2026 Jan 1;43(1):32-38. doi: 10.1097/WNP.0000000000001146. Epub 2025 Jan 28.
- Mosharaf MP, Alam K, Gow J, Mahumud RA. Cytokines and inflammatory biomarkers and their association with post-operative delirium: a meta-analysis and systematic review. Sci Rep. 2025 Mar 6;15(1):7830. doi: 10.1038/s41598-024-82992-6.
- Maldonado JR. Neuropathogenesis of delirium: review of current etiologic theories and common pathways. Am J Geriatr Psychiatry. 2013 Dec;21(12):1190-222. doi: 10.1016/j.jagp.2013.09.005.
- Gottesman RF, Grega MA, Bailey MM, Pham LD, Zeger SL, Baumgartner WA, Selnes OA, McKhann GM. Delirium after coronary artery bypass graft surgery and late mortality. Ann Neurol. 2010 Mar;67(3):338-44. doi: 10.1002/ana.21899.
- LaHue SC, Douglas VC, Kuo T, Conell CA, Liu VX, Josephson SA, Angel C, Brooks KB. Association between Inpatient Delirium and Hospital Readmission in Patients >/= 65 Years of Age: A Retrospective Cohort Study. J Hosp Med. 2019 Apr;14(4):201-206. doi: 10.12788/jhm.3130.
- Shamsi T, Janga SR, Baskaran NU, Rangasamy V, Ramachandran RV, Chen M, Ganesh S, Novack V, Subramaniam B. Temporal Trends and Severity of Postoperative Delirium in Cardiac Surgery: Insights from a Systematic Review and Meta-analysis. J Cardiothorac Vasc Anesth. 2025 Sep;39(9):2424-2435. doi: 10.1053/j.jvca.2025.05.020. Epub 2025 May 17.
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Altri numeri di identificazione dello studio
- 2026ZDSYLL134-P01
- 82572527 (Altro numero di sovvenzione/finanziamento: The National Natural Science Foundations of China)
- 82272211 (Altro numero di sovvenzione/finanziamento: The National Natural Science Foundations of China)
- BK20252100 (Altro numero di sovvenzione/finanziamento: The General Natural Science Foundation of Jiangsu Province)
- zdyyxy29 (Altro numero di sovvenzione/finanziamento: Jiangsu Province High-Level Hospital Pairing Assistance)
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