rSVO₂ and Postoperative Delirium Prediction (NCT06961994) | Clinical Trial Compass
CompletedNot Applicable
rSVO₂ and Postoperative Delirium Prediction
South Korea300 participantsStarted 2025-04-29
Plain-language summary
This prospective observational cohort study will enroll 300 patients aged ≥65 years undergoing elective noncardiac, non-neurosurgical procedures . Baseline rSVO₂ will be measured preoperatively using Near-Infrared Spectroscopy (NIRS). Intraoperative rSVO₂ will be monitored, recording the absolute lowest value and the rate of rSVO₂ decrease (\[baseline - lowest\]/baseline × 100). Postoperative delirium (POD) will be assessed daily for 7 days post-surgery using the Confusion Assessment Method (CAM). Frailty will be assessed using the Fried Frailty Phenotype. Logistic regression models, adjusted for age, ASA physical status, Charlson Comorbidity Index (CCI), hemoglobin, and intraoperative factors, will evaluate rSVO₂ metrics as predictors of POD. Linear regression will assess factors influencing the rate of rSVO₂ decrease. Pearson correlation and multivariate regression will analyze associations between POD risk factors. Receiver Operating Characteristic (ROC) analysis will compare the predictive accuracy of rSVO₂ metrics.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
1. Inclusion Criteria:
Age ≥ 65 years Scheduled for elective noncardiac, non-neurosurgical surgery under general anesthesia Expected postoperative hospital stay ≥ 2 nights Able to provide informed consent Capable of completing preoperative frailty and cognitive assessments
2. Exclusion Criteria:
History of dementia, stroke, or cerebral tumors Chronic use of antipsychotic or anticholinergic medications Inability to complete cognitive assessments (e.g., language barrier, severe hearing/vision impairment) Current hemodialysis treatment Severe jaundice Missing baseline rSVO₂ data
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.