NCT06935695招募中不适用
Surveillance Versus Prn bronChOscoPy aftEr aIrway stenTing (SCOPE-IT)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of stent-related complications warranting an intervention
研究概览
简要总结
Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.
排除标准
- •Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment.
- •Lobar or segmental stents alone
- •Terminally ill patients considered too sick to undergo a follow-up surveillance bronchoscopy
- •Stent insertion as a trial for excessive central airway collapse (as the duration of these stents is only 1-2 weeks)
- •Patients with a tracheostomy (as these patients can undergo frequent in-line suctioning that can affect the outcomes being assessed)
研究组 & 干预措施
Surveillance Group
Experimental
Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion.
干预措施: Bronchoscopy (Device)
No Surveillance
Active Comparator
Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications.
干预措施: Bronchoscopy (Device)
结局指标
主要结局
Number of stent-related complications warranting an intervention
时间窗: 3 months after enrollment
Possible complications: Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention
次要结局
- Protocol Feasibility Composite Score(3 months after enrollment)
- Number of unscheduled visits due to stent-related complications(3 months after enrollment)
- Number of hospitalizations due to stent-related complications(3 months after enrollment)
- Number of urgent care or emergency room visits due to stent-related complications(3 months after enrollment)
- Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging(3 months after enrollment)
研究者
Udit Chaddha
Associate Professor of Medicine
Icahn School of Medicine at Mount Sinai
研究点 (1)
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