Randomized Study Comparing the Oral and Nasal Routes for Linear Endobronchial Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Patient comfort and satisfaction
研究概览
简要总结
The aim of this study is to determine if the insertion of the linear endobronchial ultrasound bronchoscope is more comfortable for patients when done through the nose compared to its insertion through the mouth. Our hypothesis is that nasal insertion is more comfortable.
详细描述
Linear endobronchial ultrasound (EBUS) now plays a crucial role in the diagnosis, staging, and treatment planning of lung cancer. Most centers perform linear EBUS via the oral route given the larger diameter of the bronchoscope used. However, the feasibility and the diagnostic accuracy of linear EBUS performed through the nose have not been reported. Furthermore, the two routes of insertion have never been compared in terms of patient satisfaction and comfort.
In order to compare the two routes of insertion, consecutive patients referred for a linear endobronchial ultrasound will be recruited. Participants will be randomized to either oral or nasal insertion. All participants will be sedated and will receive local anesthetics in a similar manner. After the procedure, patients will fill a questionnaire regarding their comfort and satisfaction with the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •patients older than 18 years of age
- •patients referred for a first linear endobronchial ultrasound
排除标准
- •Patients who previously underwent an EBUS
- •Patients intubated with an endotracheal tube
- •Patients under the age of 18
- •Patients unable to provide informed consent
- •Patients currently taking anticoagulants (therapeutic doses of intravenous or subcutaneous heparin, low-molecular weight heparins, direct thrombin inhibitors or other agents)
- •Patients taking anti-platelet therapy other than aspirin (clopidogrel, ticagrelor, prasugrel). A period of 7 days off medication is required before participation.
结局指标
主要结局
Patient comfort and satisfaction
时间窗: Two hours after endobronchial ultrasound
Measured by a questionnaire using a 10-point Likert scale for both comfort and satisfaction.
次要结局
- Physician's assessment of patient comfort(Immediately after the procedure (within 10 minutes))
- Duration of endobronchial ultrasound procedure(During the procedure)
- Total doses of sedation(Immediately after the procedure (within 10 minutes))
- Occurence of pneumothorax, bleeding more than 50ml, oxygen desaturation to less than 90%, epistaxis, cardiac arrhythmia(During the procedure and up to two hours after)
- Proportion of adequate cytology specimens in each group(Days after the procedure (results usually available within 10 days))