TY - JOUR
T1 - Early preclinical experience of a mixed reality ultrasound system with active GUIDance for NEedle-based interventions
T2 - The GUIDE study
AU - Bloom, David
AU - Colombo, Jamie N.
AU - Miller, Nathan
AU - Southworth, Michael K.
AU - Andrews, Christopher
AU - Henry, Alexander
AU - Orr, William B.
AU - Silva, Jonathan R.
AU - Avari Silva, Jennifer N.
N1 - Funding Information:
We would like to acknowledge the Children's Discovery Institute Grant CH-II-2017-575. There was no funding for this study. Equipment was loaned to Washington University School of Medicine for the purposes of conducting the study. Dr Jennifer N. Avari Silva, Dr Jonathan R. Silva, Dr Christopher Andrews, and Mr Michael K. Southworth are co-inventors of the technology described. Intellectual property has been licensed to Sentiar. Dr Jennifer N. Avari Silva, Dr Jonathan R. Silva, and Mr Michael K. Southworth are co-founders of Sentiar. Mr Michael K. Southworth, Dr Christopher Andrews, and Mr Alexander Henry are employees of Sentiar. The technology has been licensed by Washington University to SentiAR. All authors attest they meet the current ICMJE criteria for authorship. All participants provided written informed consent. The authors designed the study, gathered, and analyzed the data according to the Helsinki Declaration guidelines on human research. The research protocol used in this study was reviewed and approved by the institutional review board.
Publisher Copyright:
© 2022 Heart Rhythm Society
PY - 2022/10
Y1 - 2022/10
N2 - 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™ 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.
AB - 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™ 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.
KW - Mixed reality
KW - Tool tracking
KW - Ultrasound
KW - Vascular access
KW - Vascular variant
UR - http://www.scopus.com/inward/record.url?scp=85140663938&partnerID=8YFLogxK
U2 - 10.1016/j.cvdhj.2022.07.072
DO - 10.1016/j.cvdhj.2022.07.072
M3 - Article
C2 - 36310686
AN - SCOPUS:85140663938
SN - 2666-6936
VL - 3
SP - 232
EP - 240
JO - Cardiovascular Digital Health Journal
JF - Cardiovascular Digital Health Journal
IS - 5
ER -