Continuous Oral Suctioning During Flexible Bronchoscopy: Effect on Sedative Medication Needs and Both Endoscopist's and Patient's Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Mean doses of Midazolam and Fentanyl
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of a simple intervention through a classical Yankauer oral suction tube, a device known to have a proven safety profile in multiple healthcare settings, in decreasing the sedative and opioid medication doses needed to provide effective patient sedation during bronchoscopy, along with its effect on both patient's and bronchscopist's satisfaction throughout 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
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •18 years or above
- •inpatients or outpatients
- •scheduled to have a flexible bronchoscopy for one of multiple indications based on their physician's assessment, including the presence of a lung mass or collapse, persistent pulmonary infiltrates, pulmonary infection in the setting of immunosuppression, hemoptysis, or other rare causes like chronic cough.
- •patients provided a written informed consent.
排除标准
- •patients with anatomic oro-pharyngeal abnormalities,
- •critically ill patients
- •uncooperative patients or inability to provide signed consent by the patient or their legal representative
- •coagulopathy or bleeding diathesis
- •severe obstructive airway disease
- •recent myocardial infarction
- •uncontrolled or poorly controlled asthma or chronic obstructive pulmonary disease (COPD)
- •pregnancy.
研究组 & 干预措施
Sham Group
The control group: included another 60 patients, who underwent the regular FB procedure with a blinded defective Yankauer suction device (Sham) attached to the oral cavity of the patient and present throughout the procedure.
干预措施: Bronchoscopy (Procedure)
Yankauer group
The intervention group: included 60 patients, who underwent the regular FB procedure with a functional standard Yankauer suction device attached to the oral cavity of the patient and present throughout all the procedure.
干预措施: Yankauer Suction Device (Device)
Yankauer group
The intervention group: included 60 patients, who underwent the regular FB procedure with a functional standard Yankauer suction device attached to the oral cavity of the patient and present throughout all the procedure.
干预措施: Bronchoscopy (Procedure)
结局指标
主要结局
Mean doses of Midazolam and Fentanyl
时间窗: From enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure (up to 30 minutes)
From the time of enrollment (pre-bronchoscopy) to the end of the bronchoscopic procedure
次要结局
未报告次要终点
研究者
Rayan Mohamad
Clinical Associate
American University of Beirut Medical Center