Accuracy and Safety Assessment of Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Invasive and Non-invasive Blood Pressure Monitoring in Interventional Procedures: A Prospective, Single-Center, Self-Controlled Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Agreement of Mean Arterial Pressure Between Pressure Sensing Sheath and Radial Arterial Line
研究概览
简要总结
This observational study aims to evaluate the accuracy and safety of pressure sensing sheath blood pressure monitoring compared to traditional invasive and non-invasive blood pressure monitoring methods during neuroendovascular interventional procedures.
The study will enroll 50 adult patients undergoing elective neuroendovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring. Blood pressure will be simultaneously measured using three methods: (1) pressure sensing sheath, (2) radial arterial line, and (3) non-invasive cuff monitoring.
The primary outcome is the accuracy of blood pressure measurements from the pressure sensing sheath compared to radial arterial line measurements. Secondary outcomes include the incidence of access site complications, procedure duration, patient comfort scores, and cost-effectiveness analysis.
This prospective, single-center study will be conducted at Shanghai Fourth People's Hospital Affiliated to Tongji University from August 2025 to May 2027.
详细描述
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Detailed Description for ClinicalTrials.gov Registration
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BACKGROUND
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Current State of Blood Pressure Monitoring in Interventional Procedures
Real-time, accurate hemodynamic monitoring is crucial during various interventional procedures. Currently, the clinical "gold standard" for continuous invasive arterial blood pressure monitoring is achieved through peripheral arterial catheterization (typically radial artery) connected to a pressure transducer, known as Radial Artery Catheterization (RAC). Although RAC provides beat-to-beat blood pressure data, it has several inherent limitations.
First, RAC insertion is an additional invasive procedure requiring extra time and technical skill, potentially delaying the start of the primary procedure. Studies have shown that RAC insertion requires an average of 10.7 minutes of additional time, with delays exceeding 80 minutes possible in complex cases. Second, the catheterization process may cause patient discomfort; research indicates that approximately 31.6% of patients experience pain after RAC insertion, with about 30% finding the pain bothersome. Additionally, RAC is associated with various potential complications, including radial artery occlusion (incidence approximately 5.5%), hand ischemia, infection, and thrombosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Patients scheduled for elective transradial interventional procedures requiring continuous invasive blood pressure monitoring
- •Patients who must undergo radial arterial catheterization for invasive blood pressure monitoring according to clinical needs and standard medical operational procedures
- •Patients who can understand the study purpose, voluntarily participate and sign informed consent, and are willing to undergo relevant examinations and clinical follow-up
排除标准
- •Contraindications to radial artery access
- •Hemodynamic instability
- •Patients requiring postoperative continuous invasive blood pressure monitoring
- •Failure to obtain informed consent
- •Known severe aortic or subclavian artery stenosis or occlusion
- •Severe coagulation dysfunction (INR ≥2.0, platelet count <75×10⁹/L)
- •BMI >40 kg/m²
- •Severe heart failure (NYHA Class IV) or patients requiring emergency rescue with hemodynamic instability
研究组 & 干预措施
All Participants
All enrolled patients will receive simultaneous blood pressure monitoring using both methods: (1) Pressure sensing sheath monitoring system inserted via radial artery, and (2) Traditional radial arterial line monitoring on the contralateral side combined with standard non-invasive blood pressure cuff monitoring. This is a self-controlled study design where each patient serves as their own control.
干预措施: Pressure Sensing Sheath Monitoring (Device)
All Participants
All enrolled patients will receive simultaneous blood pressure monitoring using both methods: (1) Pressure sensing sheath monitoring system inserted via radial artery, and (2) Traditional radial arterial line monitoring on the contralateral side combined with standard non-invasive blood pressure cuff monitoring. This is a self-controlled study design where each patient serves as their own control.
干预措施: Radial Arterial Line Monitoring (Device)
结局指标
主要结局
Agreement of Mean Arterial Pressure Between Pressure Sensing Sheath and Radial Arterial Line
时间窗: Intraoperative (duration of procedure, approximately 1-4 hours)
Agreement analysis of mean arterial pressure (MAP) measurements between pressure sensing sheath monitoring and radial arterial line monitoring using Bland-Altman method. Non-inferiority criterion: 95% limits of agreement within ±10 mmHg. Synchronous comparison of both methods in the same patient to eliminate individual differences.
次要结局
- Procedural Efficiency(From patient entry to operating room until completion of procedure setup (approximately 10-30 minutes))
- Agreement of Systolic and Diastolic Blood Pressure(Intraoperative (duration of procedure, approximately 1-4 hours))
- Incidence of Access Site Complications(From procedure start through 7 days post-procedure)
- Patient-Reported Puncture Site Pain Score(24 hours and 7 days post-procedure)
研究者
Yibin Fang
Head of the Department of Cerebrovascular Diseases, Clinical Professor
Shanghai Fourth People's Hospital Tongji University