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NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization

NCT07246148 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Cerebral Aneurysms
  • Intracranial Aneurysms
  • Coil Embolization
  • Hemodynamic Instability
  • Noninvasive Cardiac Monitoring

Interventions

DEVICE

Non-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.

DEVICE

Invasive arterial blood pressure monitoring

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

Sponsors & Collaborators

  • Korea University Anam Hospital

    lead OTHER

Principal Investigators

  • Jang Hoon Kim, M.D., Ph.D. · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-06-01
Completion
2027-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246148 on ClinicalTrials.gov