Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Oxygen Saturation % by Pulse Oximetry
研究概览
简要总结
This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD), most commonly used being High frequency vest airway clearance system (VEST) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis (CF) ages 6 -21 years. The primary hypothesis is that there is no effect of PIAPD on Forced expiratory volume in 1 second (FEV1) 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD. If both are equally effective, the latter device provides an alternative that is both cheaper and portable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 6-21 years
- •Cystic fibrosis stable by physician assessment
- •Assents to forego additional experimental treatments during the study
- •Currently using and familiar with airway clearance therapy for treatment of cystic fibrosis
- •Participant (or parent or legal guardian if the participant is a minor) is willing to provide -----Informed Consent
排除标准
- •FEV1 < 40% predictive
- •Pneumothorax
- •Hemoptysis
- •Coronavirus disease (COVID) 19 diagnosis within last 14 days
- •Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant
- •Additional Exclusion Criteria: Outpatient Arm (in addition to general exclusion criteria above) Decrease in FEV1 > 10% from baseline over last 12 months Antibiotic Initiation for acute CF exacerbation Hospitalization for CF Exacerbation
- •Additional Exclusion Criteria: Inpatient Arm (in addition to general exclusion criteria above) Failure to increase FEV1 > 10 % from initial Pulmonary function testing (PFTs) on admission by day 9 of hospitalization.
结局指标
主要结局
Oxygen Saturation % by Pulse Oximetry
时间窗: O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2
oxygen saturation will be obtained by home pulse oximeter device.
次要结局
未报告次要终点