A Study Comparing Advanced Hemodynamic Monitoring Using MostCare to Standard Monitoring During Propofol Sedation for ERCP Procedures

What this Trial Is About

This research aims to evaluate whether advanced hemodynamic monitoring using the MostCare system provides better detection and management of hemodynamic events requiring intervention compared to standard monitoring alone during propofol sedation for ERCP procedures. ERCP is a less invasive procedure used to treat biliary and pancreatic duct disorders, often performed in elderly patients who face challenges in anesthesia and sedation due to hemodynamic fragility and other health conditions. The study focuses on improving perioperative hemodynamic management to maintain adequate organ perfusion and oxygen delivery during these procedures. Participants will be assigned to one of two groups one receiving standard monitoring during ERCP sedation, which includes non-invasive blood pressure, electrocardiography, peripheral oxygen saturation, and bispectral index monitoring and the other receiving standard monitoring plus advanced hemodynamic monitoring with the MostCare system. The MostCare device uses arterial waveform analysis to continuously assess parameters like cardiac output, stroke volume, and systemic vascular resistance. Sedation will be provided with midazolam and propofol following the study protocol. During the study, participants will be monitored from the start of sedation until the end of the ERCP procedure to record hemodynamic events that require clinical intervention. Researchers will collect advanced and standard monitoring data to compare outcomes. The primary measure is the number of such events during the procedure. The study is randomized and parallel in design, with no masking, and participants health and procedure tolerance will be closely observed throughout the trial period.

Advanced vs Standard Hemodynamic Monitoring During Propofol Sedation for ERCP: A Prospective Study