Robotic-assisted Bronchoscopy Under Moderate Sedation With Propofol: A Single-center Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- histopathological classification of the pulmonary lesion
研究概览
简要总结
In this study, the investigators want to find out whether robot-assisted bronchoscopy also works with moderate sedation (Propofol), as is already used in standard bronchoscopies. The study is being conducted as a pilot study. This means that it is an initial test run for a scientific investigation. The investigators are testing on a small scale whether the intervention works as predicted before a larger study is conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •informed consent signed by the subject
- •aged at least 18 years
- •scheduled for bronchoscopy with moderate sedation and tracheal intubation in order to obtain at least 1 specimens of the lung via transbronchial biopsy
- •necessary periinterventional laboratory examinations needed for the bronchoscopy
- •judgement of the subject
排除标准
- •endobronchial lesion causing lobar atelectasis
- •inability or contraindications to undergo bronchoscopy (e.g. severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation, psychiatric disorders or severe neurosis)
- •pregnant or lactating women
研究组 & 干预措施
Robotic-assisted bronchoscopy with Propofol
干预措施: Robotic-assisted bronchoscopy under propofol (Device)
结局指标
主要结局
histopathological classification of the pulmonary lesion
时间窗: From enrollment to the end of treatment at 8 days.
Confirmation of tool-in-lesion
时间窗: during the intervention
Composite outcome defined as meeting at least one of the following criteria: 1) Radiological confirmation of the biopsy tool located within the target lung lesion using cone-beam CT. 2) Positive signal on radial endobronchial ultrasound (rEBUS) indicating the lesion was reached. 3) Pathological confirmation of specific malignant or benign tissue in the biopsy sample.
Acquisition of at least one histological sample
时间窗: during the intervention
次要结局
- Procedure duration(during the intervention)
- Diagnostic yield of biopsies(From enrollment to the end of treatment at 8 days.)
- diagnostic accuracy for malignancy(From enrollment to the end of treatment of 3 months)
- cost analysis(From enrollment to the end of treatment at 8 days.)
- Safety profile(From enrollment to the end of treatment at 8 days.)