A Randomized Controlled Trial on Non-Invasive Continuous Blood Pressure Monitoring as an Alternative to Radial Arterial Catheterization in Patients Undergoing Coil Embolization for Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intra-procedural hemodynamic instability events (hypotension or hypertension events)
研究概览
简要总结
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.
详细描述
Intracranial aneurysm coil embolization is a widely accepted treatment for unruptured aneurysms, but the procedure is frequently accompanied by hemodynamic instability, particularly episodes of hypotension and hypertension, which may increase the risk of neurological or cardiovascular complications. Continuous and reliable arterial blood pressure monitoring is therefore critical during the periprocedural period.
The conventional standard of care has been invasive arterial blood pressure (IABP) monitoring using a radial arterial catheter. Although IABP provides accurate real-time hemodynamic data, it is associated with procedural risks such as bleeding, hematoma, arterial occlusion, distal ischemia, infection, and patient discomfort. These risks are particularly relevant in patients undergoing neuroendovascular procedures where vascular access and anticoagulation may already increase complication risk.
The ClearSight™ system (Edwards Lifesciences, Irvine, CA, USA) is a non-invasive continuous blood pressure monitoring device that uses a finger cuff based on the volume clamp method and pulse contour analysis. Previous studies have validated its use in a variety of surgical and perioperative settings, including obese patients, vascular surgery, and cardiac surgery [Kim et al., 2014; Maheshwari et al., 2018; Bugarini et al., 2021; Chapalain et al., 2024]. However, its role as a primary monitoring modality during neuroendovascular procedures has not been fully established.
This randomized controlled trial (NOVA study) is designed to determine whether non-invasive continuous blood pressure monitoring (NVBP) can serve as a safe and effective alternative to radial IABP in patients undergoing coil embolization for unruptured intracranial aneurysms. Patients will be randomized in a 1:1 ratio to receive either NVBP monitoring (experimental arm) or standard IABP monitoring (control arm). All participants will also undergo cerebral oxygenation monitoring with O₃® Regional Oximetry (Masimo, CA, USA) to detect potential cerebral desaturation events.
In the NVBP group, invasive arterial pressure will not be obtained from a radial catheter but may be secondarily recorded from a femoral arterial catheter used for the endovascular procedure itself. Importantly, the femoral arterial waveform will not be displayed to the anesthesiologist but will be recorded by nursing staff to ensure patient safety and allow for event adjudication if NVBP and IABP values diverge significantly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NVBP group
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.
干预措施: Non-invasive continuous blood pressure monitoring (Device)
IABP group
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.
干预措施: Invasive arterial blood pressure monitoring (Device)
结局指标
主要结局
Intra-procedural hemodynamic instability events (hypotension or hypertension events)
时间窗: During the procedure (Day 0)
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.
次要结局
- Use of vasoactive medications(During the procedure (Day 0))
- Dose of vasoactive medications (vasopressors or antihypertensives)(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))
- length of stay in ICU(Discharge day (typically postoperative 2 - 7 days))
- Event detection rate of NVBP vs IABP(Postoperative Day 30)
- 30-day mortality(Postoperative Day 30)
- Major complications within 30 days(Postoperative Day 30)
- Cerebral oxygen desaturation events(During the procedure (Day 0))
研究者
JangHun Kim
Principal Investigator
Korea University Anam Hospital