Accuracy and Safety Assessment of Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Invasive and Non-invasive Methods in Neuroendovascular Procedures: A Prospective, Single-Center, Self-Controlled Randomized Study

What this Trial Is About

Researchers are evaluating the accuracy and safety of a pressure sensing sheath for blood pressure monitoring during neuroendovascular procedures compared to traditional methods such as radial arterial line catheterization and non-invasive cuff monitoring. This study focuses on adult patients undergoing elective transradial interventional procedures requiring continuous invasive blood pressure monitoring. It is a prospective, single-center, self-controlled randomized trial designed to provide high-quality evidence, particularly in a Chinese patient population, to better understand the performance and clinical suitability of this new monitoring technology. Patients enrolled will have simultaneous blood pressure measurements taken using three methods: the pressure sensing sheath inserted via the radial artery, a traditional radial arterial line placed in the opposite arm, and a standard non-invasive blood pressure cuff. The study randomizes which arm receives each invasive monitoring method and measures blood pressure at specific time points during the procedure lasting approximately 1 to 4 hours. The trial also evaluates procedural efficiency, patient comfort, and the incidence of access site complications, with follow-up visits extending to seven days post-procedure. Participants will attend four study visits: enrollment, intraoperative monitoring, and follow-ups at 24 hours and seven days after the procedure. During these visits, researchers will collect data on blood pressure readings, procedural timing, complications, patient-reported pain scores, and safety assessments using clinical examinations and ultrasound. Continuous data quality control and equipment calibration ensure accurate measurement. The primary outcome is the agreement of mean arterial pressure measurements between the pressure sensing sheath and radial arterial line during the procedure, with secondary outcomes including safety and patient comfort measures.

Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional Procedures