NCT01430962已完成不适用
Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Diagnostic Yield
研究概览
简要总结
The purpose of the study is to determine if there are any differences in yield or safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) (a type of bronchoscopy with biopsy) performed under general anesthesia versus moderate sedation.
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
- 否
入选标准
- •All patients over the age of 18, evaluated by pulmonary physician that require EBUS TBNA for sampling of hilar and/or mediastinal lymphadenopathies or masses
- •Patients should be considered eligible to undergo either CS or GA, without contraindications for either one of them, based on the assessment by the pulmonologist who will perform EBUS-TBNA
排除标准
- •Pregnancy or breastfeeding women
- •Patients deemed poor candidates for general anesthesia by the evaluating physician (e.g., severe coronary artery disease, COPD with FEV1 < 1 liter, uncontrolled hypertension, increased intracranial pressure, reaction to anesthetics)
- •Previous reaction to medications routinely used in conscious sedation
- •Patients with history of intolerance to either general anesthesia or conscious sedation
- •Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study
结局指标
主要结局
Diagnostic Yield
时间窗: 24 months
次要结局
- Time to recovery from anesthesia(24 months)
- Complications rate(24 months)
- Tolerance to procedure(24 months)
研究者
Roberto Casal
Assistant Professor of Medicine
Baylor College of Medicine
研究点 (1)
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