NCT04837625招募中不适用
A Multicenter Prospective Registration Study of Myasthenic Crisis in China
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- MG-ADL of 3 years after off-mechanical ventilation
研究概览
简要总结
This study is a multicenter, prospective, observational research. It will register the basic demographic information, medical history characteristics, clinical features, auxiliary examinations, treatment, outcomes of tracheal intubation/ventilator related events, and clinical outcomes of Myasthenic Crisis patients. The objectives including:
- Obtain epidemiological data of MC in China;
- Establish a standardized registration system for MC patients in China;
- Explore the epidemiology, clinical characteristics, serological characteristics, clinical characteristics of MC, predisposing and predictive factors, extubation process/time, weaning/extubation outcome and predictors of clinical outcome in Chinese MC patients.
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
- 否
入选标准
- •clinical history and signs of fluctuating weakness and fatigability;
- •seropositivity forAChR/MuSKantibodies;
- •If negative or the tested antibodies, positive repetitive nerve stimulation(RNS) at low frequency(2-5Hz) is required;
- •Crisis: a serious, life-threatening, rapid worsening of MG requiring intubation or noninvasive ventilation to avoid intubation.
- •Impending crisis: rapid clinical worsening of MG that, in the opinion of the treating physician, could lead to crisis in the short term (days to weeks) with blood gases suggest hypoxia (oxygen saturation <95%) or elevated carbon dioxide (paco2>50mmHg).
排除标准
- •the RNS had over 100% increase after high frequency stimulation or R2 repeats,to differentiate from lambert-Eaton syndrome and congenital MG.
- •except when intubation or noninvasive ventilation are employed during routine postoperative management.
结局指标
主要结局
MG-ADL of 3 years after off-mechanical ventilation
时间窗: Sep,2026
次要结局
未报告次要终点
研究者
研究点 (1)
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