Actively Recruiting
Non-Invasive Continuous Blood Pressure Monitoring vs Radial Arterial Catheterization During Coil Embolization for Intracranial Aneurysms
Led by Korea University Anam Hospital · Updated on 2026-04-09
50
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether non-invasive continuous blood pressure monitoring (NVBP) with the ClearSight system can safely replace invasive radial arterial catheterization (IABP) during coil embolization for unruptured intracranial aneurysms. The trial aims to see if NVBP detects blood pressure changes during surgery as reliably as IABP and whether NVBP reduces the need for invasive monitoring without affecting patient safety or outcomes. This randomized controlled trial compares patients receiving NVBP versus standard IABP monitoring during the procedure. Participants are randomly assigned to either NVBP monitoring using a finger cuff device or to traditional invasive arterial blood pressure monitoring via radial artery catheter. Both groups also receive cerebral oxygenation monitoring with near-infrared spectroscopy. The NVBP group does not have radial arterial catheterization but may have a femoral arterial catheter as a backup for safety, which is not visible to the anesthesiologist but recorded for review. Standard anesthesia and postoperative care protocols are followed for all participants. During the study, patients will have continuous blood pressure and cerebral oxygen monitoring throughout the embolization procedure. Researchers will track blood pressure events, use of medications to control blood pressure, cerebral oxygen desaturation, intensive care admissions, hospital stay length, and complications up to 30 days after surgery. The main outcome measured is the occurrence of intraoperative hypotension or hypertension events. Safety and clinical outcomes will be monitored carefully to evaluate whether NVBP can offer a less invasive monitoring option.
CONDITIONS
Brief Title
NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 19 to 80 years scheduled for elective coil embolization of unruptured intracranial aneurysms under general anesthesia
- American Society of Anesthesiologists (ASA) physical status classification I to III
You will not qualify if you...
- 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 or higher)
- Patients who are hemodynamically unstable before or expected to be unstable during the perioperative period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (procedure day)
Participants undergo coil embolization for unruptured intracranial aneurysms with either non-invasive continuous blood pressure monitoring using the ClearSight system or standard invasive arterial blood pressure monitoring via radial arterial catheterization. Cerebral oxygen saturation is also monitored during the procedure.
1 procedure visit (in-person)
Duration - Up to 30 days post-procedure
Participants are monitored for postoperative outcomes including hospital and ICU length of stay, complications, and survival up to 30 days after the procedure.
1 to 3 visits depending on recovery and assessments
Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
Research Team
E
Eunji Ko, M.D., Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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