Optimizing central venous catheterization training with affordable platform technology

The National Institute of Biomedical Imaging and Bioengineering awarded Medulate LLC $339,866 on September 1, 2026, under the Discovery and Applied Research for Technological Innovations to Improve Human Health program (CFDA 93.286) to develop a commercial prototype of the SOPHIA platform for central venous catheterization training and evaluation.

SOPHIA is an independent, whole-procedure CVC training and assessment system that enables training on all three CVC access sites (internal jugular, subclavian, femoral) within a single platform, operating through a graphical user interface with step-by-step guided training and assessment. The predecessor research prototype (DHRT+), developed through prior R01 grants, demonstrated significant improvements in resident performance and learning gains and reduced clinical CVC errors by up to 46 percent compared to manikin training. The current project addresses limitations in the research prototype by developing a novel tool sensing methodology to eliminate environmental lighting impacts on sensing accuracy, expanding training to include all three central line access sites with clinical decision training, and creating software to assign and monitor resident training.

Medulate LLC, located in State College, Pennsylvania, will perform the work through August 31, 2027. The project is structured as a Phase I Small Business Innovation Research award, advancing the platform toward commercial viability for widespread medical training deployment.

Abstract

There is a high morbidity and mortality rate associated with central venous catheterization (CVC) due to the high incidence of preventable complications. A leading cause of this high incidence rate is the experience of the physician performing the procedure; a physician who has placed less than 50 lines is twice as likely to commit an error. Through the proposed work, medulate will develop a commercial prototype of the sophia (simulation for optimal performance and high-impact assessment) platform. Sophia is the first and only independent, whole procedure CVC training and evaluation system that allows training on all three CVC sites (internal jugular, subclavian, femoral) within a single platform. Sophia operates independently, providing step-by-step guided training and assessment through a graphical user interface. The research prototype (dhrt+) of the system was developed through two R01's and was shown to significantly improve resident internal jugular CVC performance, improve learning gains and resident self-efficacy, and reduce clinical CVC errors by up to 46% compared to manikin training. However, the system is limited by the use of AI tool tracking, the training of only one central line access site (IJ) without clinical decision training, and the lack of software to assign and monitor resident training. This project aims to overcome these hurdles and convert the dhrt+ research prototype to the sophia platform commercial prototype through three aims: specific aim 1: develop a novel tool sensing methodology to eliminate impact of environmental lighting conditions on sensing accuracy: a robust "in skin" sensing platform will be developed to accurately sense the type and position of tools entering the phantom skin tissue and enable procedure specific software to sense any medical tools position. This system will replace the current AI based tool and hand tracking system that's reliability is significantly impacted by environmental conditions. Specific aim 2: develop sophia platform technology for comprehensive vein access training: advanced training modules and platform-based ultrasound imaging will be developed to develop platform CVC training to include femoral and subclavian CVC training. CVC site selection scenarios will also be developed and integrated that focus on key critical thinking to select appropriate actions when placing a CVC in complex cases (e.g. patient with coagulopathy, severe trauma, unusual anatomies, emergency situations). Specific aim 3: develop sophia sync training management software for coordinators: sophia sync, an advanced training management software for the sophia platform that enables simulation center staff and residency education program coordinators to assign training and monitor resident progress will also be developed. This software will enable staff to track completion rates, identify key errors during the training program, and ensure comprehensive oversight of the educational process.