Monitoring brain oxygen levels during carotid artery surgery
Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy
This study is testing if monitoring brain oxygen levels during carotid artery surgery can help reduce the risk of strokes and other complications for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06406842 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between local cerebral oxygenation monitoring and the risk of postoperative stroke in patients undergoing carotid endarterectomy. It aims to implement a management strategy that utilizes real-time monitoring of cerebral oxygen index to optimize cerebral blood flow autoregulation during surgery. By evaluating the effectiveness of this approach, the study seeks to reduce the incidence of neurological complications following the procedure. The research focuses on patients scheduled for elective surgery and assesses their cerebral oxygen levels to guide hemodynamic management.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-80 scheduled for elective carotid endarterectomy with an ASA classification of II or III.
Not a fit: Patients with preoperative cognitive impairment, a history of neurosurgery, or those on psychotropic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative strokes in patients undergoing carotid endarterectomy.
How similar studies have performed: While the specific approach of monitoring cerebral oxygenation in this context is novel, similar studies have shown promise in improving outcomes in surgical patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for elective carotid endarterectomy * ASA Ⅱ or Ⅲ * aged 18-80 years old Exclusion Criteria: * preoperative moderate and severe cognitive impairment * preoperative psychotropic medication history within one year * history of neurosurgery * have speech or language impairments
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- 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.