A Study to Collect Imaging Data for the Validation of the Intelligent Ultrasound's ScanNav Anatomy Peripheral Nerve Block (PNB) - US v1.0
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ScanNav Anatomy PNB highlighting misidentification of structures
研究概览
简要总结
This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to evaluate the clinical performance of ScanNav Anatomy PNB when highlighting anatomical structures during UGRA scanning. Specifically, we aim to assess and quantify the correct/incorrect highlighting of anatomical structures associated with ScanNav Anatomy PNB during UGRA scanning.
详细描述
Background:
The American Society of Regional Anesthesia and Pain Medicine (ASRA) has published evidence-based assessment of ultrasound-guided regional anesthesia (Neal et al., 2010) concluding that ultrasound guidance is superior or equal to other non-ultrasound nerve localization techniques. A subsequent publication from ASRA (Neal et al., 2016), has strengthened their position of ultrasound guidance being superior than other methods, including for the reduction of local anesthetic systemic toxicity. However, ultrasound-guided regional anesthesia (UGRA) is a difficult technique to master. A key activity of UGRA is ultrasound image interpretation (Sites et al., 2009) which ScanNav Anatomy PNB is designed to support. The data collected during this study will be assessed by a panel of intended users (experts in UGRA) to evaluate the performance and safety of ScanNav Anatomy PNB device highlighting.
Statistical Methodology:
Validation analyses will be conducted once the data collection has been complete. The collected scans will be processed, and the device output will be generated post hoc. Device output will be presented with raw ultrasound side-by-side. A panel of at least three expert anesthesiologists will review and evaluate each processed scan. The majority view of the panel will be used to evaluate each endpoint for any given structure ScanNav Anatomy PNB is intended to highlight.
Data collection and scan processing:
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 60 Years（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.
- •Vaccinated against SARS-CoV-2
排除标准
- •Aged <18 years of age;
- •Unwilling or unable to provide informed consent.
- •BMI> 39 kg/m2
- •Known pathology of the area to be scanned
结局指标
主要结局
ScanNav Anatomy PNB highlighting misidentification of structures
时间窗: 6 months
Frequency of misidentification of structures \[% of total, per anatomical region\]
次要结局
- ScanNav Anatomy PNB highlighting identification of structures(6 months)
- ScanNav Anatomy PNB safety issues(6 months)
- ScanNav Anatomy PNB adverse events(6 months)