RecruitingNot ApplicableNCT07246148

NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm 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


Sponsor

Korea University Anam Hospital

Enrollment

50 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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.

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Interventions

DEVICENon-invasive continuous blood pressure monitoring

Continuous arterial blood pressure monitoring using a finger-cuff technology (e.g., ClearSight system). Applied in the experimental NVBP group.

DEVICEInvasive arterial blood pressure monitoring

Standard radial arterial catheterization for continuous invasive blood pressure monitoring. Applied in the IABP control group.


Locations(1)

Korea University Anam Hospital

Seoul, South Korea

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NCT07246148


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