Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Success in the identification of nerve tissue by the use of an algorithm based on a multiple frequency impedance measurement (MFIM) algorithm. The outcome is binary (success vs failure).
研究概览
简要总结
A novel algorithm for bioimpedance measurements to detect nerve tissue, and discriminate it from other tissue types has been developed in a porcine model, by analysing a complex impedance dataset based on multiple measurement frequencies. It must now be confirm that the previous results are applicable in humans. Measurements from 24 predefined needle positions will be obtained in 16 of the 32 volunteers that are included in the study (part A). A new algorithm to detect nerve tissue will be developed based on these measurement results. Further impedance algorithms will be developed for other tissue type. The efficacy of the algorithms (sensitivity and specificity) will be evaluated in the 16 following volunteers (part B).
研究设计
- 研究类型
- Observational
- 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
- •Age ≥ 18 years
- •American society of anaesthesiologists score (ASA) 1 or 2
- •Volunteers that have given informed written consent
排除标准
- •Volunteers that cannot cooperate for the examination
- •Volunteers with neurologic disease, nerve- or vascular impairment
结局指标
主要结局
Success in the identification of nerve tissue by the use of an algorithm based on a multiple frequency impedance measurement (MFIM) algorithm. The outcome is binary (success vs failure).
时间窗: From day 1 up to 12 months
次要结局
未报告次要终点
研究者
Axel Rudolf Sauter
PhD
Oslo University Hospital