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临床试验/NCT05583032
NCT05583032已完成不适用

A Randomised Prospective Evaluation of the Long-Term Impact of Assistive Artificial Intelligence on Anaesthetists' Ultrasound Scanning for Regional Anaesthesia

IntelligentUltrasound Limited1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2022年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Block identification (long-term)

研究概览

简要总结

A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia.

详细描述

This is a randomised, blinded interventional prospective study which will be conducted and reported as per the Consolidated Standards of Reporting Trials - Artificial Intelligence (CONSORT-AI) guidance. The study end points have been defined prospectively, and data will be divided into two cohorts (with vs without ScanNav Anatomy PNB assistance). Participants will be asked to perform ultrasound (US) scanning on healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance, both with and without the device. The US scans will be recorded and blinded expert observers (without knowledge of whether ScanNav Anatomy PNB is in use) will also assess acquisition of an appropriate block view (panel of three experts, one viewing each scan as per the unblinded assessors). The initial assessment will be undertaken after a scanning tutorial and then repeated after 8-10 weeks (to assess longer-term impact of the device).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Anaesthetist in Stage 1 of UK Anaesthesia Core/Specialty Training (CT 1-3)
  • Able to comprehend and sign the Informed Consent prior to enrolment in the study
  • Available to travel and attend the study day in person

排除标准

  • Aged <18 years of age
  • Unwilling or unable to provide informed consent
  • Expert in UGRA (see definition above)

结局指标

主要结局

Block identification (long-term)

时间窗: 8-10 weeks

Identification of an appropriate block view by participant \[blinded expert's opinion; Y/N\] both with and without the use of ScanNav Anatomy PNB for ultrasound scanning (8 - 10 weeks after teaching)

次要结局

  • Anatomy identification(Time 0 and 8-10 weeks)
  • Participant confidence(Time 0 and 8-10 weeks)
  • Overall scan performance(Time 0 and 8-10 weeks)
  • Block identification (immediate)(Time 0)

研究者

发起方
IntelligentUltrasound Limited
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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