Here we present a novel, ultraportable and easy to use ultrasound-based vein visualization prototype developed to detect well-perfused veins at depth that provides a coronal view of vein pathways in the forearm. The device aims to meet the clinical need to reduce first-pass cannulation failure rates present with landmark and infrared-based techniques, while providing an affordable and usable technique improving upon cart-based ultrasound assisted techniques. The prototype aims to utilize the precision and reliability of ultrasound visualization, while presenting the information in an unambiguous and clear light-weight method to improve the ability for clinicians to visualize veins prior to cannulation.
The prototype was able to accurately locate a variety of simulated veins in vitro. The tested variables encompass the range typically cannulated or seen within human forearms [19–21] and therefore our prototype is likely to be capable of accurately detecting most human adult veins that are suitable for PIVC insertion. This forms the detection limits of this prototype which signal and coupling optimization will improve in future prototypes.
The ease of maintaining a sterile workflow is critical in preventing cross contamination between the imaging device and patient during cannulation. To facilitate the use of the imaging prototype in a sterile manner, a consumable sheath compatible with the ultrasound prototype was developed to easily integrate into the current sterile cannulation workflow. The usability and ease-of-use of the prototype sheath and workflow was demonstrated in an early usability study, which confirmed that all users were able to maintain a sterile environment with minimal assistance. Prior to implementation and testing in educational programs our findings suggest that improvements are required for the provided training, which will include the introduction of a task analysis and incorporating labels into the sheath design to further improve the success of maintaining a sterile field. The results show that future sheath iterations can plausibly be integrated into current sterile cannulation workflow and that the intended sterile workflow would not be a detriment to maintaining sterility.
Additional to the sterile workflow, a proposed “clean” workflow has also been developed following the World Health Organization (WHO) “Guidelines for the prevention of bloodstream infections and other infections associated with the use of intravascular catheters” [22]. This guideline suggests that insertion of PIVCs should be completed as a clean procedure using an aseptic “no-touch” technique (ANTT), where there is a focus on non-contacting areas that could cause infection (ie insertion site, catheter tip). The prototype sheath and “clean” workflow would adhere to a clean environment, where there is a less burdensome approach for deploying and using the sheath in comparison to a sterile environment.
Within the in vivo trial, the prototype performed well in deep veins (93%; >4.64mm), detecting the deepest vein identified at 9.26mm, moderately deep vessels (3-15mm) have been shown to be a more successful cannulation site [23]. This highlights the ability for our novel device to outperform infrared based cannulation assisting devices, as they were unable to accurately measure below a depth of 6mm [16]. The prototype also performed well in veins that had flow faster than 39.8mm/s (95%), higher flow rates have been indicated to provide better perfusion for cannulation [24]. There is a reduction in performance in in smaller veins < 3.27mm (88%), which can be a characteristic for difficult intravenous access patients such as children, however future optimizations can address this need for pediatric application [13]. There is a limitation with the current prototype as the sensor transducer element pitch is 1.2mm, therefore resolution and detection of smaller veins can be improved by decreasing the pitch.
The prototype sensitivity data highlights a high sensitivity rate for veins that were difficult to visualise with the naked eye (91%), veins with no palpable appearance (83%), veins of self-identified DIVA patients (87%), and veins in participants with a tanned-to-dark skin tone (95%). Over a third of patients (16), have veins with these characteristics and the ability of the prototype to detect 94% of them, indicates high potential for reducing first pass insertion failure (1,2). Whilst there was a decrease in the device sensitivity to non-palpable veins, the device outperformed landmark technique visualisation and palpation by 104% and 25%, respectively.
Despite the many strengths of the prototype and study, there are more limitations worth noting. Within the in vivo study, the procedure was on healthy participants who were assumed to have minimal differences in vessel characteristics compared to typical in-patients requiring cannulation. These continuous variables measured, including age, depth, velocity, and diameter, had limited range, and age was particularly skewed, as seen in Appendix A. We intend on repeating the study on a wider variety of participants. Other limitations included sensitivity being recorded after finding a suitable vein with standard ultrasound [Clarius L15 HD3 High Frequency Linear Ultrasound Scanner, Vancouver, Canada], introducing bias. The ultrasound operator was a product engineer, not an officially trained clinician. Lastly, The device is an early prototype with planned software and hardware optimization, including the transducer optimization, that will enhance the applicability to a more diverse range of venous anatomy and patient groups (e.g. children).
The study presented a novel ultrasound-based vein visualization prototype device which detects well-perfused veins at depth and provides the coronal view of vein pathways. The results illustrate promising accuracy of the early-stage prototype, working in both phantoms and key anatomical insertion sites of healthy patients, thus providing a strong foundation for future pilot human studies. The continued usability trials inform prototype development to improve form factor and workflow integration, increasing the prototype ability to accurately identify and display vein location whilst maintaining sterility. The goal of this study was to measure the performance of the prototype without software enhancement or optimisation, anticipating that as our device continues to be developed the performance will continue to improve, making it an extremely useful tool for clinicians to use and lowering their risk of peripheral cannula insertion failure.