Using EEG to predict postoperative delirium in older patients
Electroencephalographic Biomarker to Predict the Development of Postoperative Delirium: a Protocol of an Observational Study in a Cohort of Patients From Five Centers
University of Chile · NCT05992506
This study is testing if brain wave patterns during surgery can help predict if older patients will experience confusion after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 264 (estimated) |
| Ages | 60 Years to 100 Years |
| Sex | All |
| Sponsor | University of Chile (other) |
| Locations | 2 sites (Santiago and 1 other locations) |
| Trial ID | NCT05992506 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the use of intraoperative EEG analysis as a biomarker for predicting postoperative delirium (POD) in older patients undergoing high-risk elective surgery. The research will involve a multicenter approach across five institutions, focusing on patients aged 60 and above who require at least three days of hospitalization post-surgery. By employing a predictive model called PEUMA, which utilizes EEG data, the study seeks to improve early diagnosis and risk assessment for POD, which is a significant complication affecting long-term outcomes. The primary endpoint is to assess the effectiveness of PEUMA in predicting the occurrence of POD.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 60 and older scheduled for high-risk elective surgery requiring general anesthesia and a hospital stay of at least three days.
Not a fit: Patients with preoperative delirium, dementia, or those undergoing emergency surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of postoperative delirium, enhancing patient outcomes and reducing healthcare costs.
How similar studies have performed: Previous studies have explored EEG as a predictive tool for cognitive dysfunction, but this specific approach using PEUMA is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 60 years old * Scheduled for high-risk elective surgery * Need for at least 3 days of hospital stay after surgery * Surgery performed under general anesthesia * Written informed consent for participation in the trial Exclusion Criteria: * Patients with preoperative delirium or dementia * Patients using neuroleptics drug during the past 6 months * Patients with a history of encephalopathy, psychosis, stroke or brain trauma with neurologic sequels * The use of ketamine or dexmedetomidine during surgery * Emergency surgery * Mechanical ventilation during the 72 after surgery * Analphabetism * Patients who do not talk Spanish * Patients included in another clinical trial
Where this trial is running
Santiago and 1 other locations
- Hospital Clinico Universidad de Chile — Santiago, Chile (RECRUITING)
- Instituto Nacional del Cancer — Santiago, Chile (RECRUITING)
Study contacts
- Study coordinator: Jose I Egana, MD, PhD
- Email: jiegana@uchile.cl
- Phone: +56 2 2978 8209
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Delirium, EEG, Risk Assessment, Anesthesia