Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional Procedures
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
Shanghai Fourth People's Hospital Tongji University
50 participants
Aug 1, 2025
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria8
- 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
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Interventions
Continuous 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.
Traditional 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.
Locations(1)
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NCT07257367