Evaluating Pressure Sensing Sheath Accuracy and Safety Compared to Traditional Blood Pressure Monitoring During Neuroendovascular Procedures A Prospective, Self-Controlled Study in Adults Undergoing Elective Interventional Procedures

What this Trial Is About

This observational study evaluates the accuracy and safety of a pressure sensing sheath for blood pressure monitoring during neuroendovascular interventional procedures. It compares this new device to traditional invasive radial arterial line monitoring and standard non-invasive cuff monitoring in adult patients undergoing elective procedures. The study aims to address limitations of current methods, such as procedure delays and patient discomfort, by assessing the new technology within a Chinese population. Participants will receive simultaneous blood pressure monitoring from both the pressure sensing sheath inserted via the radial artery and the traditional radial arterial line on the opposite side, along with standard cuff measurements. The study uses a self-controlled randomized design where each patient serves as their own control. The research includes four clinical visits enrollment, intraoperative monitoring, 24 hours post-procedure, and 7 days post-procedure to collect data on monitoring accuracy, procedural efficiency, safety, and patient comfort. During the study, researchers will gather continuous blood pressure readings and analyze the agreement between devices using statistical methods. They will also monitor for complications at the access sites and assess patient pain and comfort. Data quality will be ensured through standardized procedures and real-time monitoring. The total participant involvement spans from enrollment through 7 days after the procedure, with the primary outcome focused on comparing mean arterial pressure accuracy during the procedure.

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