Dynamic Multimodal Delirium Warning After Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-80
SponsorSoutheast University, China
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Cardiac Surgery Patients
Trial outcomes
Primary outcomes
1
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).
Time frame
From ICU admission until ICU discharge or Day 7 postoperatively, whichever occurs first.2
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.
Time frame
From end of surgery until first documented delirium or ICU discharge, up to 7 days.3
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.
Time frame
From first delirium onset until delirium resolution or ICU discharge, up to 7 days.Secondary outcomes
1
Duration of Mechanical Ventilation
Total time (in hours) from endotracheal intubation to successful extubation (or removal of ventilatory support) during the index ICU stay.
Time frame
From ICU admission until extubation, assessed throughout ICU stay, up to 30 days.2
Intensive Care Unit Length of Stay
Total number of days spent in the ICU from the date of ICU admission to the date of ICU discharge.
Time frame
From ICU admission to ICU discharge, up to 30 days.3
Hospital Length of Stay
Total number of days from hospital admission (for cardiac surgery) to hospital discharge.
Time frame
From hospital admission to hospital discharge, up to 90 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: