Development and Testing of an Ultrasound Guided Automated Spinal Landmark System uSINE for Spinal Anaesthesia in Adults with and without Obesity

What this Trial Is About

Researchers are evaluating an ultrasound guided automated spinal landmark identification system called uSINE to improve the safety and success of neuraxial needle insertion during spinal anesthesia. The study addresses limitations of the traditional blind palpation method, which can lead to multiple needle insertion attempts and complications. This study involves four phases focusing on technology development and clinical evaluation, especially in obese patients where anatomy is more challenging. The study uses ultrasound gel and a wireless ultrasound probe to scan the lumbar spine and identify spinal landmarks in real-time. In the first phase, 20 non-obese patients undergoing neuraxial anesthesia will have the system used to guide needle insertion. The second phase involves scanning 50 obese patients backs without needle insertion to develop an obesity-specific visualization mode. The third and fourth phases involve collecting ultrasound images and testing the systems accuracy and first-attempt success rate in 65 obese patients. Participants will assume a seated position for ultrasound scanning of the lower back. The procedure includes longitudinal and transverse scans to identify the sacrum, interspinous spaces, and ligamentum flavum. The primary outcome is the first attempt success rate of spinal anesthesia, measured within 12 hours. Secondary outcomes include the number of attempts, time to identify ligamentum flavum, and distance from skin to ligamentum flavum. The study monitors all phases until completion planned by the end of 2027.

An Ultrasound Guided Automated Spinal Landmark Identification System