A Pilot Study to Evaluate Anaesthetists' Ultrasound Scanning & Interpretation Performance for Ultrasound-guided Regional Anaesthesia - With & Without the Assistance of an Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Correct identification of appropriate block site (at initial assessment and 2 months later)
研究概览
简要总结
This is a single-centre, randomised, interventional prospective cohort study to be undertaken at offices of Intelligent Ultrasound Limited in Cardiff, United Kingdom.
详细描述
Current National Institute for Health and Care Excellence (NICE) guidance (NICE, 2009) supports the use of ultrasound-guidance for regional anaesthesia (UGRA) procedures as a consensus of clinical opinion agrees that nerve blocks are more successful and safer with ultrasound (US) guidance. Despite this, UGRA remains a difficult technique to master. This study will be used to determine whether ScanNav Anatomy PNB can support the performance of non-expert anaesthetist in UGRA scanning by highlighting key anatomical structures on the US image in real time.
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
- 是
入选标准
- •Male or female, at least 18 years of age
- •Able to comprehend and sign the Informed Consent prior to enrolment in the study
- •Available to travel and attend the study day in person in Cardiff, UK
- •Medical professional (currently practicing anaesthetist or similar clinician) who is qualified to perform UGRA
- •Do not self-identify as an expert in the field of UGRA:
- •Has not completed advanced training or hold a qualification (e.g., EDRA, MSc, MD, PhD) related to UGRA
- •Does not regularly deliver anaesthesia for 'awake' surgery (excluding central neuraxial techniques)
- •Does not teach on formal RA courses
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
Correct identification of appropriate block site (at initial assessment and 2 months later)
时间窗: 12 months
Quantify the performance change associated with ScanNav Anatomy PNB during UGRA scanning: (for block regions of the upper limb, trunk, and lower limb). Correct identification of appropriate block site by participant \[expert observer's opinion; Y/N\]
次要结局
- Time required to scan (at initial assessment and 2 months later)(12 months)
- confidence in identifying an appropriate block site (at initial assessment and 2 months later)(12 months)
- Quantify the change in incorrect identification of safety critical anatomical structures (at initial assessment and 2 months later)(12 months)
- Expert observer's assessment (at initial assessment and 2 months later)(12 months)
- Correct identification of key structures (at initial assessment and 2 months later)(12 months)