Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist)
研究概览
简要总结
The goal of this pilot single-arm crossover trial is to investigate the feasibility and safety of using single-use flexible bronchoscopes (SUFB) for routine diagnostic and therapeutic interventional pulmonary procedures instead of reusable flexible bronchoscopes (RFB). The main questions it aims to answer are:
Was a decision to crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) made ?
Bronchoscopist's assessment of the SUFB for each procedure (using a Likert scale 0-10) including:
- Overall assessment
- Scope quality
- Scope handling
- Scope maneuverability
- Tool compatibility
- Suction
- Lavage
- Safety
- Image quality
Participants will undergo bronchoscopy with single use bronchoscopes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age 18 or older
- •Able to provide informed consent.
排除标准
- •Emergent procedure
- •Study subjects have any diseases or conditions that interferes with safe completion of the biopsy including: cardiopulmonary instability; sensitivity to drugs that could be administered during bronchoscopy; active anticoagulation or antiplatelet therapy (warfarin, direct Xa inhibitors, thrombin inhibitors, low molecular weight heparin, unfractioned heparin, clopidogrel) not held adequately prior to the procedure; uncontrolled blood dyscrasias; concurrent pneumothorax or bullae.
研究组 & 干预措施
Use of single use bronchoscope
干预措施: Single use bronchoscope (Device)
结局指标
主要结局
Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist)
时间窗: During the procedure
次要结局
未报告次要终点
研究者
Adnan Majid, MD
Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology,
Beth Israel Deaconess Medical Center