Actively Recruiting

Phase Not Applicable
Age: 19Years - 80Years
All Genders
NCT07246148

NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization

Led by Korea University Anam Hospital · Updated on 2026-04-09

50

Participants Needed

1

Research Sites

86 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization

Who Can Participate

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 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
Not Eligible

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 due to peripheral vascular disease, skin disorders, absence of radial/ulnar artery, or upper extremity orthopedic conditions
  • 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

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Trial Site Locations

Total: 1 location

1

Korea University Anam Hospital

Seoul, South Korea, 02841

Actively Recruiting

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Research Team

E

Eunji Ko, M.D., Ph.D.

CONTACT

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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