Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Peak oscillating expiratory airflow measurements
研究概览
简要总结
The study will be an open label laboratory study with all subjects receiving HFCWO with The Monarch® System
Objective:
Assess device settings and to identify frequency/pressure (intensity) combinations that produce high airflow and oscillating volume
Methodology:
Subjects will receive HFCWO using The Monarch® System at multiple frequency / intensity combinations on a single visit day. Frequency / intensity combinations will be evaluated to determine which settings produce highest airflow and highest oscillating volume.
详细描述
The study will be an open-label, laboratory study. All enrolled subjects will receive HFCWO therapy with the Monarch® system. The study will be conducted at one (1) site in the US.
The study will evaluate oscillating airflow and oscillating volume induced during therapy with the Monarch® system. Subjects will also rate the comfort of the therapy. Patients with cystic fibrosis (CF) who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study.
Therapy with the Monarch® system will be delivered using multiple frequency/intensity combination settings. The order of settings will be randomized for each study subject. During therapy oscillating flow and volume measurements will be obtained for each frequency/intensity combination. Following each frequency/intensity combination, subjects will respond to a subjective assessment of the comfort of the therapy by rating the comfort on a visual analogue scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of CF (by sweat test and/or genetics
- •Age > 15 years
- •Require regular home airway clearance therapy
- •Current user of The Monarch® System with a minimum of 4 weeks experience with the device
- •Signed informed consent. If patient is a minor, parents/guardians must give written informed consent and patient must give written assent
- •Patient must be on a stable regimen of CF medication
排除标准
- •History of pneumothorax within the past 6 months prior to study visit
- •History of hemoptysis requiring embolization within the past 12 months prior to study visit or hemoptysis of > 100 ml within a 24-hour period within the past 30 days
- •History of lobectomy
- •Recent chest surgery or chest trauma
- •Inability to perform The Monarch® System therapy as directed
- •Pregnant or lactating female
- •Have a pacemaker or implantable cardioverter defibrillator (ICD)
- •Requirement for oral or IV antibiotics that are not part of the subject's usual course of treatment within the past 14 days prior to screening
结局指标
主要结局
Peak oscillating expiratory airflow measurements
时间窗: 4-6 hours
Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings. After adjusting the therapy to the desired setting, subjects will be instructed breath through the mouthpiece for the flow measurement system, to breathe normally and continue relaxed breathing. Oscillating flow and volume measurement will be captured by the system over a period of 30 to 60 seconds of relaxed breathing. Data from the measurement of oscillating flow for each frequency/intensity combination setting will be processed following the completion of the testing
次要结局
- Oscillating volume(4-6 hours)
- Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS)(4-6 hours)