Efficacy of Med Systems' Electro Flo Percussor Model 5000, Airway Clearance System, for Pulmonary Clearance of Secretions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage change of oxygen levels in the blood (pulse oximetry).
研究概览
简要总结
Phase IV interventional study of adults (18 to 55) having a diagnosis of cystic fibrosis (mild, moderate or severe). The study is completely voluntary and is designed to measure participants use and the effectiveness of the device within the 510K indication of: airway clearance therapy when external manipulation of the thorax. The trial period shall be 21 days and include use of a FDA cleared pulse oximetry monitor (K131111), manual spirometer as well as completion of semi-weekly participant survey.
详细描述
Phase IV interventional study, of participants with cystic fibrosis with mild, moderate or severe conditions, for the efficacy of the Electro Flo Percussor, Model 5000 (K031876), Regulation Number: 21 CFR 868.5665, with current FDA indication of: provide airway clearance therapy when external manipulation of the thorax is the physician's choice of treatment. Indications for this form of therapy are described by the American Association for Respiratory Care (AARC) in the Clinical Practices Guidelines for Postural Drainage Therapy ( I ) (1991). According to AARC guidelines, specific indications for external manipulation of the thorax include evidence or a suggestion of retained secretions, evidence that the patient is having difficulty with the secretion clearance, or presence of atelectasis caused by mucus plugging. In addition, the Med Systems Electro Flo Percussor Model 5000 is also indicated for external manipulation of the thorax to promote airway clearance or improve bronchial drainage for purposes of collecting mucus for diagnostic evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously diagnosed with cystic fibrosis (mild, moderate or severe)
- •Prescribed (licensed medical provider) airway clearance device/system for at home, self-treatment for airway clearance
- •Physically able to perform self-treatment or treatment by an at home medical provider
排除标准
- •History of tobacco use
- •History of excessive alcohol consumption, more than 2 drinks per day, 10 per week
- •Any other medical condition that would preclude use of an airway clearance device
- •Previously diagnosed with major cardiological disease
结局指标
主要结局
Percentage change of oxygen levels in the blood (pulse oximetry).
时间窗: Change from baseline up to 3.5 hours.
SpO2 will be monitored using the standard pulse oximeter system (K131111).
次要结局
- Percentage change of lung function(Change from baseline up to 3.5 hours)
研究者
Leigh J. Mack
Principal Investigator (CEO)
Mack Biotech, Corp.
