Validation Study of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy
试验速览
- 阶段
- 不适用
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
研究概览
简要总结
Evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist.
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
- •adult patients admitted to Intensive care unit
排除标准
- •patients in terminal conditions
- •patients with peroneal nerve exam not feasible ( for example with presence of prostheses, wounds, plaster casts, edema of the limbs)
结局指标
主要结局
specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
时间窗: up to the comlpete execution of the two peroneal nerve exams, at most an hour
DTComPair-package in R
sensitivity and specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
时间窗: up to the comlpete execution of the two peroneal nerve exams,at most an hour
DTComPair-package in R
次要结局
- evaluation of concordance between peroneal nerve test performed by an intensivist compared to peroneal nerve test performed by a neurophysiopathologist considering the test as a continuous variable(up to the comlpete execution of the two peroneal nerve exams, at most an hour)
- correlation between hospital mortality and abnormal peroneal nerve test(up to hospital discharge, an average of 6 months)
- correlation between hospital discharge destination and abnormal peroneal nerve test(up to hospital discharge, an average of 6 months)
研究者
Elisa Seghelini,MD
Principal Investigator
Università degli Studi di Brescia