Impact of High Flow Therapy Through Nasal Cannula on Complications Related to Airway Stenting: a Prospective, Multicentric, Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- incidence of respiratory infection associated with airway stent in nebulized saline group
研究概览
简要总结
The application of HFNC therapy in patients with airway stent, improving both humidification and clearance of the airway secretion, could potentially reduce the risk of mucoid impaction, respiratory infections and granulation. HFNC therapy could be superior to nebulization of normal saline (usual care) in order to keep the stent cleaned, reducing, by inference, the risk of complications, as defined above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Written informed consent
- •Central Airway obstruction, both malignant and nonmalignant, treated with airway stenting (silicone or fully covered metallic stent)
排除标准
- •Contraindication to HFNC (recent - within 3 months - nose surgery or facial trauma)
- •Lack of written informed consent
- •Neuropsychiatric disorders
- •Pregnancy
结局指标
主要结局
incidence of respiratory infection associated with airway stent in nebulized saline group
时间窗: within 90 days from stent placement
symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy
incidence of mucous plugging associated with airway stent in nebulized saline group
时间窗: within 60 days from stent placement
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of granuloma associated with airway stent in HFNC group
时间窗: within 90 days from stent placement
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of granuloma associated with airway stent in nebulized saline group
时间窗: within 90 days from stent placement
granuloma formation assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
incidence of respiratory infection associated with airway stent in HFNC group
时间窗: within 90 days from stent placement
symptoms of respiratory infection + radiologic and/or bronchoscopic signs of infection + need of antibiotic therapy
incidence of mucous plugging associated with airway stent in HFNC group
时间窗: within 90 days from stent placement
mucous plugging assessed during bronchoscopy, eventually determining reduction in cross-sectional stent area
次要结局
- mortality due to respiratory infection in nebulized saline group(within 90 days from stent placement)
- mortality due to respiratory infection in HFNC group(within 90 days from stent placement)
- adherence to home treatment with HFNC in patients with airway stent, as assesed by time of daily utilization(within 90 days from stent placement)
- adherence to home treatment with nebulization of normal saline in patients with airway stent, as assesed by time of daily utilization(within 90 days from stent placement)
- Satisfaction of home treatment with HFNC by Cough and sputum assessment questionnaire (CASA-Q)(within 90 days from stent placement)
- incidence of adverse events due to home treatment with HFNC in patients with airway stent(within 90 days from stent placement)
- incidence of adverse events due to home treatment with nebulization of normal saline in patients with airway stent(within 90 days from stent placement)
- Satisfaction of home treatment with nebulized saline by Cough and sputum assessment questionnaire CASA-Q(within 90 days from stent placement)
- incidence of airway stent colonization in HFNC group(within 90 days from stent placement)
- incidence of airway stent colonization in nebulized saline group(within 90 days from stent placement)
- all cause-mortality in HFNC group(within 90 days from stent placement)
- all cause-mortality in nebulized saline group(within 90 days from stent placement)
研究者
Giuseppe Failla
Chief of Interventional Pulmonology Unit
Cardarelli Hospital