From feasibility study to randomised control trial: the evolution of a novel neuraxial procedure device

Abstract

IntroductionNeuraxial procedures are performed by many specialties among a wide variety of patients. Palpation is the standard practice to locate a target insertion site. Procedural difficulty may prompt the use of alternative modalities. In a 2020 feasibility study, a neuraxial imaging device called VerTouch was shown to be reliable and easy to learn. In this study, we compared VerTouch to palpation and ultrasound (US).MethodsAn investigator-initiated prospective, randomised study was conducted on a labour and delivery ward at a large tertiary care hospital. Participants were randomised to either palpation, US or the VerTouch device. The primary endpoint was the total number of redirections. Secondary endpoints included the number of reinsertions and the total procedure time.Results95 patients were enrolled and 81 completed the study. The VerTouch group required fewer redirections (0.72 vs 2.35 and 2.81, p=0.041) and reinsertions (0.11 vs 0.50 and 0.96, p=0.017) without prolonging the overall procedure time (8.66 mins vs 7.88 and 9.81, p=0.121) when compared to palpation and US, respectively.ConclusionThis study supports the potential for VerTouch to improve procedural success for patients who might otherwise require radiology referral and for providers who may lack the resources or training to accommodate US guidance. The results also demonstrate the potential value in clinician involvement in the development of technology from the point of inception through implementation into clinical practice.