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NCT07257367
Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional Procedures
Conditions: Blood Pressure Monitoring, Neuroendovascular Procedures
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: Shanghai Fourth People's Hospital Tongji University
Location: Shanghai Fourth People's Hospital Tongji University Shanghai Shanghai Municipality
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 Criteria
Inclusion Criteria:
* 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 Criteria:
* 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 \40 kg/m²
* Severe heart failure (NYHA Class IV) or patients requiring emergency rescue with hemodynamic instability
Source: ClinicalTrials.gov (NCT07257367). StuddyBuddy aggregates publicly available trial information.