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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Korea University Anam Hospital
RECRUITING
Seoul
Contact Information
Primary
Eunji Ko, M.D., Ph.D.
froken.ko@gmail.com
+82-10-3423-8249
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 50
Treatments
Experimental: NVBP group
Participants undergo continuous non-invasive blood pressure (NVBP) monitoring using the ClearSight system (Edwards Lifesciences, Irvine, CA, USA) during coil embolization for intracranial aneurysm. Cerebral oxygen saturation is simultaneously monitored with O₃® Regional Oximetry (Masimo, CA, USA). A femoral arterial catheter placed for endovascular access may serve as a backup for safety, but invasive radial arterial catheterization is not performed.
Active_comparator: IABP group
Participants undergo standard invasive arterial blood pressure (IABP) monitoring via radial arterial catheterization during coil embolization. Cerebral oxygen saturation is also monitored with O₃® Regional Oximetry (Masimo, CA, USA), identical to the NVBP group.
Sponsors
Leads: Korea University Anam Hospital

This content was sourced from clinicaltrials.gov