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.
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
Contraindications to radial artery access
Hemodynamic instability
Patients requiring postoperative continuous invasive blood pressure monitoring
Failure to obtain informed consent
Adult patients (≥18 years) undergoing elective neuroendovascular interventional procedures requiring general anesthesia and continuous invasive blood pressure monitoring at Shanghai Fourth People's Hospital Affiliated to Tongji University. Target enrollment is 50 patients from September 2025 to December 2026.
Cohort
Prospective
Pressure Sensing Sheath Monitoring
DeviceContinuous invasive blood pressure monitoring via pressure sensing sheath inserted through radial artery during interventional procedure. The pressure sensing sheath integrates a miniature pressure sensor within the vascular access sheath, enabling simultaneous vascular access and continuous blood pressure monitoring.
Radial Arterial Line Monitoring
DeviceTraditional invasive blood pressure monitoring via radial arterial catheterization (RAC) on the contralateral radial artery, combined with standard non-invasive blood pressure cuff monitoring. This serves as the gold standard comparator for blood pressure measurement accuracy.
Agreement of Mean Arterial Pressure Between Pressure Sensing Sheath and Radial Arterial Line
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.
Agreement of Systolic and Diastolic Blood Pressure
Bland-Altman analysis of systolic (SBP) and diastolic (DBP) blood pressure agreement between the two monitoring methods. Calculate Pearson correlation coefficient and Lin's concordance correlation coefficient.
Procedural Efficiency
Time required to establish stable blood pressure monitoring from puncture initiation, procedure preparation time, and impact on total procedure duration.
Incidence of Access Site Complications
Composite of puncture-related complications including: vasospasm, hematoma, infection, thrombosis, pseudoaneurysm formation, vessel occlusion, and neurological impairment. Assessed at multiple time points: intraoperative, 24 hours post-procedure, and 7 days post-procedure.
Patient-Reported Puncture Site Pain Score
Visual Analog Scale (VAS) pain score (0-10 points) for puncture site discomfort and impact on daily activities.
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