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临床试验/NCT04983771
NCT04983771已完成不适用

Anatomical Validity of Experts and ScanNav Anatomy PNB When Identifying Sono-anatomical Structures for Ultrasound-Guided Regional Anaesthesia

IntelligentUltrasound Limited1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年9月1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
19
试验地点
1
主要终点
Experts' variability

研究概览

简要总结

This is a multi-centre, prospective, observational study, conducted under the auspices of the University of Oxford to evaluate ultrasound image analysis by human experts and an artificial intelligence device in the context of ultrasound-guided regional anaesthesia (UGRA).

详细描述

Ethical Approval:

The ultrasound scans/still frame images used in this study have been acquired from an earlier study conducted at Oregon Health & Science University (OHSU) (ClinicalTrials.gov ref: NCT04906018). OHSU Institutional Review Board approval (STUDY00022920) was granted for collection of the ultrasound scans.

Ethical approval for the assessment of these scans by regional anaesthesia experts, has been obtained from Oxford University Research Ethics Committee for Medical Sciences (R75449/RE001).

Block Areas Included:

A Delphi study was undertaken earlier in the research programme: 'International Consensus on the Minimum Anatomical Structures to Identify on Ultrasound for the Performance of Plan A Blocks in Ultrasound-Guided Regional Anaesthesia: A Regional Anaesthesia UK Delphi Study' (work currently unpublished).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Member of a relevant professional society (e.g., RA-UK, ESRA, ASRA) and meets at least three of the following criteria:
  • Completed advanced training in UGRA or have >10 years of independent practice in UGRA
  • Hold a qualification related to UGRA (e.g., EDRA, higher degree or equivalent)
  • Regularly delivers direct clinical care using UGRA, including for 'awake' surgery where indicated
  • Regularly teaches UGRA in the course of their clinical work, including advanced techniques (Plan B/C/D blocks) where indicated

排除标准

  • 未提供

结局指标

主要结局

Experts' variability

时间窗: 2 years

Assess variability in identification of key anatomical structures on ultrasound by individual members of the expert panel

ScanNav anatomy PNB comparison

时间窗: 2 years

Compare the identification of anatomical structures on ultrasound images by an artificial intelligence system to the combined assessment of a panel of experts

次要结局

未报告次要终点

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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