Feasibility of First Pass Cannulation Success Rate in Peripheral Intravenous Cannulation on Adults Using a Novel Ultrasound Device

This study aims to evaluate the usability and clinical effectiveness of the VeinWise device, a portable, ergonomically designed handheld system that displays simplified pathways of veins reconstructed from ultrasound data. The primary objective is to assess the device's performance in facilitating vein visualization during peripheral intravenous cannulation (PIVC), which is one of the most commonly performed medical procedures. The study will not involve direct comparisons with other devices but will focus on assessing the standalone functionality and user experience of the VeinWise prototype in a controlled clinical environment. The novel ultrasound device that will be used for this study will be the VeinWise ultrasound device, which has not been regulatory approved. This is a portable and handheld prototype that displays simplified pathways of veins reconstructed from continuous wave doppler ultrasound data. The prototype was assembled under ISO13485 Quality Management Systems and safety has been ensured through risk assessment. The device weighs less than 200g, it scans an area of the forearm 20x30mm and displays the scanned area 1:1 on a screen. The device is designed to be held in a clinicians non-cannulating hand, visualising the vessel pathway to enable clinicians to align their catheter in the correct location and angle. An off-the-shelf ultrasound probe cover is placed around the device to maintain sterility. Sterile ultrasound gel is placed under the sensor to ensure signal transmission. The device is then placed on the participants forearm. Patients will be recruited in this study, as well as voluntary clinical professionals. Each patient will be recruited face to face, and their participation will last ~1 hour. It will occur in a Hospital. Each clinician will be recruited face to face, and their participation will range but will likely involve, 1 training session and ~3 cannulations. Clinicians have access to revisit all training material, plus quick-reference guides before every cannulation. During the procedure, clinicians will assess the patients forearm vessels using the device, if they are confident to cannulate a vessel they will then attempt cannulation with device visualisation assistance. If successful the patient will answer questions about their experience. Following one failed attempt (only one attempt will be permitted), the Vascular Access Specialist will insert the cannula using commercial ultrasound. To ensure safe and effective use of the device and to answer any technical queries, a product engineer will be present during the procedures. Training involves clinicians reading an instructions for use manual, watching a workflow video, and performing cannulation on a simulation forearm model made of silicone. Adherence or fidelity to the use of the device will not be formerly assessed, however the technical expert will always be present to ensure safe and proper workflow adherence.