Electromyographic Assessment of the TetraGraph in Normal Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Comparison of train of four measurements between TOF Watch and TetraGraph
研究概览
简要总结
There is an urgent need for an easy-to-use and accurate quantitative neuromuscular monitor in the clinical setting. The aim of this clinical investigation is to examine a prototype of a quantitative monitoring instrument that will meet most, if not all, of the clinical requirements.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of train of four measurements between TOF Watch and TetraGraph
时间窗: During stimulation
The primary endpoint will be an analysis of the agreement between the TOF-Watch (the current gold standard) and TetraGraphTM devices during neuromuscular monitoring. Data Acceleromyography (AMG) and Electromyography (EMG) will be compared between the two devices during testing of single twitch (ST) and train of four (TOF) patterns at varying current amplitudes, from threshold amplitude (the lowest current amplitude that is able to generate a muscle response), to supramaximal current amplitude (the amplitude that elicits maximal muscle response). Bias and limits of agreement will be calculated for each stimulation pattern (ST and TOF) at currents between submaximal and supramaximal amplitude. Measured responses obtained with the two technologies (AMG and EMG) will be compared.
次要结局
- EMG amplitude(During stimulation)
- Discomfort level(During stimulation)
- Noise level(During stimulation)
- Stimulus artifact(During stimulation)
- Maximal EMG amplitude(During stimulation)
- Appearance EMG response(During stimulation)
- Consistency in amplitude(During stimulation)
研究者
J. Ross Renew, M.D.
Principal Investigator
Mayo Clinic