Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
研究概览
简要总结
This study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CF
- •Hospital admission for acute pulmonary exacerbation of CF (using Fuchs criteria 4/10)
- •10 years of age and older
- •Subject is able to comply with the procedures scheduled in the protocol
- •Signed informed consent form
排除标准
- •Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment
- •Subject had ear, nose, and throat (ENT) surgery, nasal bleeding, or nasal polyps within 6 months prior to study
- •Subject is unlikely to comply with the procedures scheduled in the protocol
- •Inability to give informed consent
- •Subject requires supplemental oxygen
- •History of obstructive sleep apnea
- •History of pressure headaches requiring therapy within one month of enrollment
- •Any other medical or psychological condition in which the study doctor(s) believe(s) would inhibit the individual from being an appropriate study subject.
研究组 & 干预措施
Experimental Therapy
High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air
干预措施: High-Flow, 20 LPM (via Optiflow cannula) (Device)
Control Therapy (Low Flow)
Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air
干预措施: Low FLow, 5 LPM (via Optiflow cannula) (Device)
结局指标
主要结局
Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)
时间窗: Day 0 to Day 6 or upon discharge from the hospital, whichever comes first
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health.
次要结局
- Sputum Collection(10 minutes)