A Pilot Study to Assess the Efficacy and Effectiveness of High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations in Children With Muscle Weakness and Restrictive Lung Disease CR-0088
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Hospitalizations Lasting at Least 24 Hours in This Patient Population
研究概览
简要总结
To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle weakness and restrictive lung disease.
详细描述
This non-randomized home based pre-post intervention study. The study will compare the efficacy of Vest® therapy (HFCWO) for mucus secretion clearance in a population of patients with muscle weakness and restrictive lung disease with frequent pulmonary exacerbations. Enrolled subjects with a tracheostomy will be evaluated for microbial load and inflammatory status as a pilot evaluation of microbial load and inflammatory status outcomes.
The total number of evaluable subjects to be recruited is estimated at 40. Subjects will be considered evaluable if they have completed at least 6 months of follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 months old.
- •Subject has a chest circumference of greater than 19 inches.
- •Subject has a diagnosis of muscle weakness and restrictive lung disease.
- •Ability to provide Informed consent from legal guardian.
- •Subject has had 2 or more exacerbations requiring either hospitalization or antibiotics (IV or oral) in the past 12 months
- •If inhaled Tobramycin has been prescribed prophylacticly, subjects must discontinue the medication at least 2 weeks prior to study enrollment
排除标准
- •Subject has a diagnosed allergy with a respiratory trigger.
- •Participation in another clinical trial.
- •Unstable head or spinal injury.
- •Unresolved pneumothorax or pneumomediastinum present
- •Unresolved hemorrhage
- •Hypotension requiring vasopressors or positioning
- •Bronchopleural fistula
- •Gross hemoptysis within the past eight hours
- •Pulmonary embolism or history of pulmonary embolism within the past two months
- •Burns, open wounds and skin infections on the thorax
- •Osteomyelitis of the ribs
- •Osteoporosis with history of fractures.
研究组 & 干预措施
Vest Treatment (HFCWO)
Patients will receive Vest treatments for airway clearance therapy 2 x daily for 12 months. These data will be compared to 12 months of data prior to Vest initiation.
干预措施: Vest Treatment (high frequency chest wall oscillation) (Device)
结局指标
主要结局
Hospitalizations Lasting at Least 24 Hours in This Patient Population
时间窗: end of study
Hospitalizations lasting at least 24 hours
次要结局
未报告次要终点