ZEBRA study: The Z stitch Early Bed Rest Assessment study

Abstract

BackgroundSafe and effective management of venous vascular access is a key component of EP procedures. Recently, the “Z stitch” method has been developed for effective venous hemostasis. However, the standard post-procedure protocol often includes prolonged bed rest, which may affect patient satisfaction. The ZEBRA study aims to systematically investigate and quantify patient satisfaction metrics and safety parameters associated with the early mobilization after “Z stitch” placement. ObjectiveThis study primarily investigates whether early mobilization following Z stitch placement in venous vascular access management during Electrophysiology (EP) procedures enhances patient satisfaction without compromising safety. MethodsIn this prospective, multicenter, randomized clinical trial, approximately 200 patients undergoing various EP procedures at OHSU and VAPORHCS will be randomly assigned to either a 1-hour or a 4-hour bed rest regimen post-Z stitch. Patient satisfaction will be assessed through survey, alongside monitoring for hematomas, bleeding complications, and other safety endpoints. The trial includes stratification based on heparin administration and sheath size to ensure robust and nuanced data analysis. ResultsWe anticipate that early mobilization will lead to higher patient satisfaction scores. We also expect to closely monitor and report the incidence of hematomas, pain medication use, healthcare costs, patient outcomes at 30 days, time to ambulation, and hospital readmissions or emergency visits related to groin complications. ConclusionThe ZEBRA study is poised to fill a critical knowledge gap in post-procedure care in EP labs. By rigorously evaluating the impact of early mobilization on patient satisfaction and safety, this study could significantly influence future guidelines and improve patient experiences in EP procedures.