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

Author:

Gaston Ian NORCID,Samworth Alexander,McCrory Emery,Bavaro Joseph,Vaidyanathan Mahesh

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.

Funder

Intuitap

Publisher

BMJ

Subject

General Medicine

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3