Monitoring brain oxygen levels to understand postoperative delirium in carotid surgery
Association Between Local Cerebral Oxygen Saturation Monitoring and Postoperative Delirium in Carotid Endarterectomy：A Prospective Cohort Study
This study is testing if monitoring brain oxygen levels during carotid surgery can help predict if older patients will experience confusion after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05198635 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between local cerebral oxygenation and the occurrence of postoperative delirium in patients undergoing carotid endarterectomy. It utilizes near-infrared spectroscopy (NIRS) to continuously monitor cerebral oxygen saturation during surgery, aiming to identify how fluctuations in oxygen levels may correlate with delirium post-surgery. The study will track patients' oxygen levels intraoperatively and collect postoperative data to establish a threshold for predicting delirium. This approach focuses on a high-risk group of elderly patients with various vascular risk factors.
Who should consider this trial
Good fit: Ideal candidates are elderly patients scheduled for carotid endarterectomy who can provide informed consent.
Not a fit: Patients with severe cognitive impairment, a history of psychotropic drug use, or previous intracranial surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and prevention strategies for postoperative delirium in high-risk surgical patients.
How similar studies have performed: While the use of NIRS for monitoring cerebral oxygenation is established, the specific association with postoperative delirium in carotid endarterectomy patients is less explored, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Scheduled carotid endarterectomy; Signed informed consent. Exclusion Criteria: Severe cognitive impairment(Mini-Mental State Examination, MMSE\<18); History of psychotropic drugs; Previous intracranial surgery history; Poor hearing or vision; Language barriers
Where this trial is running
Beijing, Beijing Municipality
- Beijing Tian Tan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Yuming MD Peng, Ph.D — Beijing Tiantan Hospital
- Study coordinator: Yuming MD Peng, Ph.D
- Email: florapym766@163.com
- Phone: 8610-59976658
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.