Non-invasive continuous blood pressure monitoring during intracranial aneurysm coil embolization
A Randomized Controlled Trial on Non-Invasive Continuous Blood Pressure Monitoring as an Alternative to Radial Arterial Catheterization in Patients Undergoing Coil Embolization for Intracranial Aneurysms
This trial tests whether the ClearSight non‑invasive continuous blood pressure monitor can safely replace radial arterial catheter monitoring for adults having coil embolization of unruptured intracranial aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07246148 on ClinicalTrials.gov |
What this trial studies
Adults undergoing elective coil embolization for unruptured intracranial aneurysms are randomized to continuous non‑invasive blood pressure monitoring with the ClearSight system or standard invasive radial arterial catheter monitoring, with both groups monitored for cerebral oxygenation (rSO₂) during general anesthesia. The study tracks detection of intraoperative hypotension and hypertension, need for conversion to invasive monitoring, and perioperative clinical outcomes and complications. Data collected include continuous hemodynamic traces, episode frequency and duration, and any procedure‑related vascular or neurologic events. While ClearSight has shown reasonable agreement with invasive arterial pressure in other surgical populations, its role as the primary monitor in neuroendovascular procedures remains to be established.
Who should consider this trial
Good fit: Adults aged 19–80 with unruptured intracranial aneurysms scheduled for elective coil embolization under general anesthesia, ASA physical status I–III, who are hemodynamically stable and able to provide informed consent.
Not a fit: Patients with peripheral vascular disease, morbid obesity (BMI ≥40), preoperative hemodynamic instability, inability to consent, or anatomical/clinical reasons preventing reliable finger cuff use or radial access are unlikely to benefit from replacing invasive monitoring.
Why it matters
Potential benefit: If successful, this approach could reduce the use of radial arterial catheters and their associated risks (bleeding, hematoma, infection, ischemia) while preserving safe intraoperative blood pressure management.
How similar studies have performed: Previous studies have validated ClearSight in various perioperative and cardiac surgery settings with reasonable concordance to invasive measurements, but its use as the primary arterial monitor in neuroendovascular coil embolization has not been fully validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥19 and ≤80 years old) scheduled for elective coil embolization of unruptured intracranial aneurysms under general anesthesia. * American Society of Anesthesiologists (ASA) physical status classification I-III. Exclusion Criteria: * Patients who do not provide informed consent. * Patients unable to understand or follow study instructions due to physical or mental limitations. * Patients in whom radial arterial catheterization is not feasible (e.g., peripheral vascular disease, skin disorders at the insertion site, absence of radial/ulnar artery, or orthopedic conditions of the upper extremity). * Patients with peripheral vascular circulatory disorders. * Patients with morbid obesity (BMI ≥ 40 kg/m²) \[Eley et al., 2021\]. * Patients who are hemodynamically unstable preoperatively or expected to be unstable during the perioperative period.
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Jang Hoon Kim, M.D., Ph.D. — Korea University Anam Hospital
- Study coordinator: Eunji Ko, M.D., Ph.D.
- Email: froken.ko@gmail.com
- Phone: +82-10-3423-8249
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.