In vitro and in vivo vein assessment of a novel vein visualizing device to improve first-time peripheral venous access

Abstract

Objective

Inserting needles into veins is fundamental to medical care with up to 90% of inpatients requiring a peripheral intravenous catheter/cannula (PIVC) during their stay. Yet 40%–50% of PIVC insertions fail on the first attempt. Here, we present an easy-to-use novel vein visualizing ultrasound prototype device and data from in vitro and in vivo performance.

Methods

Locational accuracy was determined through phantom simulated forearm veins, across variations of vein diameter (3–5 mm), depth (10–20 mm), and velocity (10–100 mm/s). Usability studies were conducted on nine clinicians to establish effectiveness and ease of use of the proposed prototype assisted cannulation workflow. Sensitivity of the prototype was demonstrated by scanning 80 forearm veins across 40 healthy volunteers.

Results

Our prototype's locational accuracy in simulated forearm veins is 0.21 mm ± 1.71 mm (s.d.) (97.7% agreement to the ground truth, p < .001). Usability studies found that 100% of users were able to handle the prototype in a sterile manner with minimal assistance. The sensitivity was excellent at finding veins (94%). In comparison, sensitivity of vein finding using landmark technique with torniquet (visible 46% and palpable 74%) were far inferior.

Conclusion

Initial performance verification and validation studies presented suggest that the proposed ultrasound visualization method can simply and reliably help clinicians detect well-perfused veins at depth and visualize in the coronal view onboard the probe in alignment with the transducers. With improved ergonomics, the device has the potential to be an easy to use device for clinicians performing vascular access.