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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Non-invasive continuous blood pressure monitoring
DeviceContinuous arterial blood pressure monitoring using a finger-cuff technology (e.g., ClearSight system). Applied in the experimental NVBP group.
Invasive arterial blood pressure monitoring
DeviceStandard radial arterial catheterization for continuous invasive blood pressure monitoring. Applied in the IABP control group.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Use of vasoactive medications
Name of vasoactive medications (vasopressors or antihypertensives) administered during the procedure
Dose of vasoactive medications (vasopressors or antihypertensives)
cumulative dose of vasoactive medications administered during the procedure.
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).
Length of hospital stay
Duration (day) of hospitalization after coil embolization until discharge.
Sponsors and contacts
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