Actively Recruiting

Phase Not Applicable
Age: 19Years - 80Years
All Genders
ID07246148

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

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
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 (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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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