Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Complications related with EBUS-TBNA
研究概览
简要总结
The purpose of this study is to find all kinds of complications and it's frequency related to the Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) and to evaluate associated risk factors in patients who developed complications. The investigators performs EBUS-TBNA examination on all subjects that need mediastinal evaluation. All complications during or after the procedure will be recorded prospectively.
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
- 否
入选标准
- •Mediastinal lymph node enlargement on chest CT or PET-CT
排除标准
- •Inadequate oxygenation during procedure
- •uncontrolled cardiac arrythmia
- •Bleeding diathesis
- •Severe thrombocytopenia
- •Recent use of clopidogrel
- •Uncooperative patients
结局指标
主要结局
Complications related with EBUS-TBNA
时间窗: 1 month interval
1. Complications during procedure * Bleeding * pneumothorax * shock * cardiac arrythmia * change of oxygen saturation 2. Complication after procedure * fever * bleeding * pneumothorax * all other comlications after 24hr
次要结局
- Risk factors related with the development of complications(1 month interval)
研究者
Kyung Jong Lee
professor
Samsung Medical Center