Actively Recruiting
Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional Procedures
Led by Shanghai Fourth People's Hospital Tongji University · Updated on 2025-12-02
50
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for elective transradial interventional procedures requiring continuous invasive blood pressure monitoring
- Must undergo radial arterial catheterization for invasive blood pressure monitoring according to clinical needs and standard medical procedures
- Able to understand the study purpose, voluntarily participate, sign informed consent, and willing to undergo examinations and follow-up
You will not qualify if you...
- Contraindications to radial artery access
- Hemodynamic instability
- Require postoperative continuous invasive blood pressure monitoring
- Unable to provide informed consent
- Known severe aortic or subclavian artery stenosis or occlusion
- Severe coagulation dysfunction (INR ≥2.0, platelet count <75×10⁹/L)
- Body mass index over 40 kg/m²
- Severe heart failure (NYHA Class IV) or requiring emergency rescue with hemodynamic instability
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Fourth People's Hospital Tongji University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yibin Fang, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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