Dynamic Multimodal Delirium Warning After Cardiac Surgery

NCT07686900 | Not Yet Recruiting

• 5 other identifiers: 2026ZDSYLL134-P018257252782272211BK20252100zdyyxy29
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium; Cardiac Surgical Procedures

Keywords

Postoperative Delirium; Cardiac Surgery; Electroencephalography; EEG; Cerebral Oximetry; Near-Infrared Spectroscopy; Hemodynamics; Multimodal Monitoring; Early Warning System

Outcome Measures

Primary Outcomes (3)

• Incidence of Postoperative Delirium (POD)

  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

  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

  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.

Secondary Outcomes (3)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda hospital Southeast University

Nanjing, Jiangsu, China

Location

Related Publications (11)

• 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.

  PMID: 41481100 RESULT

• 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.

  PMID: 28940368 RESULT

• 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.

  PMID: 40050293 RESULT

• 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.

  PMID: 24206937 RESULT

• 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.

  PMID: 23992774 RESULT

• 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.

  PMID: 20373345 RESULT

• 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.

  PMID: 30933669 RESULT

• 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.

  PMID: 22762316 RESULT

• 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.

  PMID: 18577850 RESULT

• 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.

  PMID: 40537396 RESULT

• 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.

  PMID: 30113379 RESULT

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jingyuan Xu, MD

  Southeast University School of Medicine

  STUDY CHAIR

Central Study Contacts

Jingyuan Xu, MD

CONTACT

+8613851417209; xujingyuanmail@163.com

Wanting Lin, MD

CONTACT

13523253700; linwanting2022@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Director, Department of Intensive Care Medicine

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)