Clearance Of Mucus In Stents (COMIS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Percentage of obstruction resolution as Good or Excellent
研究概览
简要总结
The goal of this clinical research study is to compare the effects of sodium bicarbonate to normal saline when used for clearing mucus blockage in patients with airway stents.
详细描述
Study Agents:
Sodium bicarbonate is also called baking soda. In this study it will be mixed with water.
Normal saline is a salt water solution.
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. The study doctor will use either sodium bicarbonate or normal saline during your bronchoscopy to clear mucus from your stent:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (>/= 18 years) with airway stents undergoing bronchoscopy.
- •Patients previously enrolled, but excluded as no stent lumen obstruction from mucus retention identified at earlier enrollment (hence excluded at that enrollment) .
排除标准
- •Patients with history of allergy or adverse reactions to sodium bicarbonate or normal saline.
- •Patients refusing to sign informed written consent for participation in research.
- •Patients with no stent lumen occlusion from mucus impaction as determined at the time of the initial visual bronchoscopic assessment.
- •Previously enrolled patients who completed this protocol.
结局指标
主要结局
Percentage of obstruction resolution as Good or Excellent
时间窗: Baseline to 7 days
Response/efficacy of sodium bicarbonate versus normal saline in airway stents graded using scale. Percentage of obstruction resolution (relative to initial stent lumen obstruction by mucus): Good response 51-75% clearance; and Excellent 76 - 100% clearance. The Mantel-Haenszel chi-square test stratified by degree of lumen obstruction at study enrollment used to compare response (good or excellent obstruction resolution) rates between treatment arms.
次要结局
未报告次要终点