NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization
South Korea50 participantsStarted 2026-01-01
Plain-language summary
The goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for unruptured intracranial aneurysms.
The main questions it aims to answer are:
* Does NVBP monitoring detect intraoperative hypotension and hypertension events with similar reliability compared to IABP?
* Does NVBP monitoring reduce the need for invasive arterial catheterization without compromising patient safety or clinical outcomes?
Researchers will compare patients assigned to NVBP monitoring with those receiving conventional IABP monitoring.
Participants will:
* Be randomly assigned to NVBP monitoring or standard IABP monitoring during coil embolization.
* Receive continuous monitoring of cerebral oxygenation with near-infrared spectroscopy (rSO₂).
* Undergo standard anesthesia induction, maintenance, and postoperative intensive care protocols.
* Have their intraoperative hemodynamic events, vasopressor use, and postoperative outcomes recorded up to 30 days after the procedure.
Who can participate
Age range
19 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intra-procedural hemodynamic instability events (hypotension or hypertension events)