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From feasibility study to randomised control trial: the evolution of a novel neuraxial procedure device
  1. Ian N Gaston,
  2. Alexander Samworth,
  3. Emery McCrory,
  4. Joseph Bavaro,
  5. Mahesh Vaidyanathan
  1. Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA
  1. Correspondence to Dr Ian N Gaston, Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611, USA; iangaston{at}


Introduction Neuraxial 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).

Methods An 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.

Results 95 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.

Conclusion This 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.

  • Anesthesiology
  • Biomedical Engineering
  • Obstetrics
  • Women's Health

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  • Contributors ING: contributed to the conception, creation, design and interpretation of data of the manuscript. AS: contributed to the creation and design of the manuscript. EM: contributed to the conception and interpretation of the data of the manuscript. JB: contributed to the interpretation of data of the manuscript. MV: contributed to the creation of the randomised control trial design and the conception, creation, design and interpretation of data of the manuscript.

  • Funding This study was funded by Intuitap (N/A).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.