rSVO₂ and Postoperative Delirium Prediction

NCT06961994 | Completed DMC

• 1 other identifier: Wonkwang UH16
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium, Postoperative

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium (POD)

  Postoperative delirium (POD) will be assessed daily for 7 days following surgery using the Confusion Assessment Method (CAM). The primary outcome is the occurrence of POD, defined as at least one positive CAM assessment during this period.

  Postoperative Days 1 to 7

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults (≥65 years) undergoing elective noncardiac, non-neurosurgical surgery under general anesthesia. Patients were recruited from a university hospital in May 2025 and will be screened for eligibility based on cognitive ability, comorbidities, and frailty status.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwang University School of Medicine Hospital

Iksan, Jeollabuk-do, 54538, South Korea

Location

Related Publications (2)

• Zhu J, Wang W, Shi H. The Association between Postoperative Cognitive Dysfunction and Cerebral Oximetry during Geriatric Orthopedic Surgery: A Randomized Controlled Study. Biomed Res Int. 2021 Oct 19;2021:5733139. doi: 10.1155/2021/5733139. eCollection 2021.

  PMID: 34712732 BACKGROUND

• Schoen J, Meyerrose J, Paarmann H, Heringlake M, Hueppe M, Berger KU. Preoperative regional cerebral oxygen saturation is a predictor of postoperative delirium in on-pump cardiac surgery patients: a prospective observational trial. Crit Care. 2011;15(5):R218. doi: 10.1186/cc10454. Epub 2011 Sep 19.

  PMID: 21929765 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

• Cheol Lee, M.D.,Ph.D

  Wonkwang University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: April 29, 2025
• Primary Completion: May 15, 2025
• Study Completion: June 5, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

KR (1)