NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorKorea University Anam Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Invasive arterial blood pressure monitoring

    Device

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: NVBP groupExperimental treatment 1 intervention
Group B: IABP groupActive comparator 1 intervention

Trial outcomes

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.

Time frame
During the procedure (Day 0)

Secondary outcomes

1

Use of vasoactive medications

Name of vasoactive medications (vasopressors or antihypertensives) administered during the procedure

Time frame
During the procedure (Day 0)
2

Dose of vasoactive medications (vasopressors or antihypertensives)

cumulative dose of vasoactive medications administered during the procedure.

Time frame
During the procedure (Day 0)
3

Cerebral oxygen desaturation events

Incidence of cerebral oxygen desaturation, defined as ≥20% decrease from baseline or an absolute value \<50 for ≥1 minute, measured by near-infrared spectroscopy (NIRS).

Time frame
During the procedure (Day 0)
4

Length of hospital stay

Duration (day) of hospitalization after coil embolization until discharge.

Time frame
Discharge day (typically postoperative 2 - 14 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.