Oscillating Lung Expansion (OLE) Therapy in the Bronchiectasis Patients (BE) Home Care Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 9
- 主要终点
- Evaluate the effectiveness of BiWaze Clear therapy in reducing the frequency of pulmonary exacerbations and improving clinical outcomes.
研究概览
简要总结
The study will examine how the performance of Oscillating Lung Expansion (OLE) therapy affects the respiratory health of patients with Bronchiectasis (BE).
The patient will use the BiWaze Clear system for their airway clearance therapy, instead of their previously prescribed therapy. BiWaze Clear is an FDA-cleared respiratory therapy for assisting patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high-frequency oscillation therapies, combined with aerosol delivery.
The patient will perform airway clearance with BiWaze Clear as prescribed. The system uses a disposable breathing circuit, which is a single patient use, disposable circuit.
The treatment duration is 6 months . The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with an oxygen supply.
详细描述
The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with an oxygen supply.
The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting. The primary objective of the study is to evaluate the effectiveness of BiWaze Clear therapy in reducing the frequency of pulmonary exacerbations and improving clinical outcomes.
The study will quantify the frequency of pulmonary exacerbations over a 6-month period during BiWaze Clear therapy and compare this data to the number of exacerbations recorded in the 12 months prior to the initiation of therapy.
A total of 85 adult and pediatric male and female patients (5+ years of age) that are diagnosed with Bronchiectasis(BE) will be enrolled into the study.
The patient will perform airway clearance therapy with the BiWaze Clear System. This system is manufactured by ABM Respiratory Care and assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The oscillating lung expansion therapy of the BiWaze Clear System is intended to reduce airway obstructions caused by secretions occupying the lower airways, prevent respiratory tract infections, re-expand the collapsed areas of the lung, thereby enhancing gas exchanges and reducing inflammatory response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Patients aged > 5 years old.
- •History of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention.
- •Ability to perform BiWaze Clear therapy as prescribed.
- •Clinically stable respiratory status at the time of screening.
- •Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).
- •Signed informed consent (and Child assent if minor subject).
排除标准
- •An individual who meets any of the following criteria will be excluded from participating in this study:
- •Diagnosis with rapidly progressing NMD.
- •Anticipated requirement for hospitalization within the next six months.
- •History of pneumothorax within the past 6 months.
- •Use of OLE therapy within the past 12 months.
- •Inability or unwillingness to perform OLE therapy or study procedures as required.
- •Currently enrolled in a different study.
- •Current smoker or tobacco use within the last 30 days.
- •Pregnancy or Breastfeeding.
- •Any medical conditions deemed by investigators to have a significant impact on the study results, e.g., active cancer, severe cardiovascular, severe progressive pulmonary disease, liver, kidney, or neurological conditions.
- •Inability to comply with the treatment protocol or study procedures.
- •Known allergies to materials used in OLE device.
研究组 & 干预措施
BiWaze Study Device treatment single Arm
All patients will be assigned to a single treatment arm utilizing BiWaze Clear System
干预措施: BiWaze Clear System (Device)
结局指标
主要结局
Evaluate the effectiveness of BiWaze Clear therapy in reducing the frequency of pulmonary exacerbations and improving clinical outcomes.
时间窗: 6 months
Quantify the frequency of pulmonary exacerbations over a 6-month period during BiWaze Clear therapy and compare this data to the number of exacerbations recorded in the 12 months prior to the initiation of therapy.
次要结局
未报告次要终点