NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization

NCT07246148 | Recruiting

• 1 other identifier: K2025-2494-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

non-invasive blood pressure monitoring; continuous arterial blood pressure monitoring; coil embolization; neuroanesthesia; cerebral oximetry; radial arterial catheterization

Outcome Measures

Primary Outcomes (1)

• Intra-procedural hemodynamic instability events (hypotension or hypertension events)

  Incidence of hemodynamic instability during coil embolization. Hypotension is defined as mean arterial pressure (MAP) \< 65 mmHg sustained for ≥ 1 minute. Hypertension is defined as systolic arterial pressure \> 120 mmHg sustained for ≥ 1 minute.

  During the procedure (Day 0)

Secondary Outcomes (9)

• Use of vasoactive medications

  During the procedure (Day 0)

• Dose of vasoactive medications (vasopressors or antihypertensives)

  During the procedure (Day 0)

• Cerebral oxygen desaturation events

  During the procedure (Day 0)

• Length of hospital stay

  Discharge day (typically postoperative 2 - 14 days)

• Incidence of ICU admission

  Discharge day (typically postoperative 2 - 7 days)

Study Arms (2)

NVBP group

EXPERIMENTAL

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.

Device: Non-invasive continuous blood pressure monitoring

IABP group

ACTIVE COMPARATOR

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.

Device: Invasive arterial blood pressure monitoring

Interventions

Non-invasive continuous blood pressure monitoring DEVICE

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

NVBP group

Invasive arterial blood pressure monitoring DEVICE

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

IABP group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jang Hoon Kim, M.D., Ph.D.

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+82-10-3423-8249; froken.ko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is conducted as a partial double-blind trial. Patients cannot be blinded to the presence or absence of a radial arterial catheter after the procedure. The anesthesiologist managing hemodynamics is also not blinded due to the differences in monitoring displays. However, the neurosurgeon performing the coil embolization, who does not have access to hemodynamic monitoring screens, remains blinded to group allocation. Outcome assessors and statisticians are fully blinded, and all event adjudications will be conducted using predefined criteria and de-identified datasets.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1 ratio into two parallel groups: the experimental arm (non-invasive blood pressure monitoring using ClearSight system) and the control arm (invasive radial arterial catheter monitoring).

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

KR (1)