Alexa K Green, RN, David M Pechman, MD, MBA, Hyunsuk Suh, MD. Mount Sinai Beth Israel
Objective of the technology or device: Ultrasound guidance has improved efficacy and decreased complication rates for a variety of procedures by allowing for dynamic identification of structures and visualization of an advancing needle. Computer-assisted instrument guidance (CAIG) complements existing ultrasound technology, further enhancing accuracy and safety of ultrasound-guided procedures. In our pilot study, surgery trainees using the Clear Guide ONE (Clear Guide Medical, Baltimore, MD) CAIG system performed simulated central venous cannulations significantly more quickly, more accurately, and with fewer needle passes relative to standard ultrasound guidance (SUG). We will next perform randomized controlled trials evaluating CAIG versus SUG in central venous catheterization and fine needle aspiration biopsies. We hypothesize that CAIG will consistently improve operator accuracy and decrease procedure-related morbidity.
Description of the technology and method of its use or application: The Clear Guide ONE (FDA approved, 510k issued in September, 2014) is an optically-based system with stereo cameras that visualize the procedure needle in three dimensions prior to insertion. The Clear Guide CORE computer is connected to the ultrasound video output and the optical head is attached to a standard ultrasound probe. Proprietary algorithms calculate a projected path of the needle, which is overlaid on the standard ultrasound image (Image 1). The operator is able to confirm correct needle orientation prior to insertion and receive real-time feedback as the needle advances, resulting in markedly improved performance.
In the pilot study, fifteen surgery residents performed simulated central venous cannulations on a training mannequin. Residents performed their first attempt at central venous cannulation using SUG. The second attempt was performed using CAIG technology. Puncture time (PT), number of skin punctures (#SP), and number of needle passes (#NP) were recorded for all attempts. Puncture time was defined as the time from skin puncture until visible venous return. Study participants were encouraged to minimize the procedure time and the number of attempts, but were blind to the purpose of the study, and were unaware that their performance was being recorded.
Image 1: The Clear Guide ONE system
Results: Relative to SUG, CAIG significantly decreased procedure duration and the number of attempts required. CAIG decreased mean PT by 27.3 seconds (79% decrease, p=0.007), #SP by 0.7 (42%, p=0.03), and #NP by 2.4 (64%, p=0.001). Greatest improvement was observed in novice ultrasound operators. Six of the fifteen participants had previously performed ten or fewer SUG procedures; for these users, CAIG decreased mean PT by 45.3 seconds (86%, p=0.03), #SP by 1.3 (57%, p=0.04), and #NP by 3.8 (70%, p=0.01).
Conclusions / future directions: The pilot study demonstrated impressive gains in accuracy, efficiency, and safety with the use of CAIG, especially for novice ultrasound operators, reflecting its potential value as a clinical and educational tool. These encouraging results are deserving of further study. We hypothesize that the use of CAIG for ultrasound-guided procedures will shorten the learning curve for trainees and that CAIG may benefit a range of interventions from bedside PICC/midline placement to intraoperative ultrasound-guided procedures.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 84394
Program Number: ETP727
Presentation Session: Emerging Technology Poster
Presentation Type: Poster