Early preclinical experience of a mixed reality ultrasound system with active GUIDance for NEedle-based interventions: The GUIDE study

BACKGROUND Use of ultrasound (US) to facilitate vascular access has increased compared to landmark-based procedures despite ergonomic challenges and need for extrapolation of 2-dimensional images to understand needle position. The MantUS (TM) system (Sentiar, Inc.,) uses a mixed reality (MxR) interface to display US images and integrate real-time needle tracking. OBJECTIVE The purpose of this prospective preclinical study was to evaluate the feasibility and usability of MantUS in a simulated environment. METHODS Participants were recruited from pediatric cardiology and critical care. Access was obtained in 2 vascular access training models: a femoral access model and a head and neck model for a total of 4 vascular access sites under 2 conditions-conventional US and MantUS. Participants were randomized for order of completion. Videos were obtained, and quality of access including time required, repositions, number of attempts, and angle of approach were quantified. RESULTS Use of MantUS resulted in an overall reduction in number of needle repositions (P = .03) and improvement in quality of access as measured by distance (P <.0001) and angle of elevation (P = .006). These findings were even more evident in the right femoral vein (RFV) access site, which was a simulated anatomic variant with a deeper more oblique vascular course. Use of MantUS resulted in faster time to access (P = .04), fewer number of both access attempts (P = .02), and number of needle repositions (P <.0001) compared to conventional US. Postparticipant survey showed high levels of usability (87%) and a belief that MantUS may decrease adverse outcomes (73%) and failed access attempts (83%). CONCLUSION Use of MantUS improved vascular access among all comers, including the quality of access. This improvement was even more notable in the vascular variant (RFV). MantUS readily benefited users by providing improved spatial understanding. Further development of MantUS will focus on improving user interface and experience, with larger clinical usage and in-human studies.