Measurement of Mucus Plugging With Computer Tomography Before and Following Implementation of the AffloVest in Adults With Bronchiectasis - a Feasibility Study'
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- High Resolution Computed Tomography (HRCT)
研究概览
简要总结
Feasibility study of High Frequency Chest Wall Oscillation (HFCWO) using the AffloVest in 30 patients with Bronchiectasis over a 6 week period. Outcome measures include lung function, quality of life questionnaire, High resolution computed Tomography and visual analogue scale for ease of clearance.
详细描述
The study is an feasibility study evaluating the impact of using the AffloVest for 30 minutes twice daily [in addition to their standard airway clearance regimen] for 6 weeks.
The study will endeavour to recruit 30 adult subjects (male and female) who have a known diagnosis of bronchiectasis and who attend the Cambridge Centre for Lung Infection (CCLI) at the Royal Papworth Hospital, Cambridge, United Kingdom.
Bronchiectasis is defined as symptoms of chronic or recurrent bronchial infection with radiological evidence of abnormal and permanent dilation of bronchi, not from cystic fibrosis. Subjects will be recruited through convenience sampling and must demonstrate stability during a 2-week period prior to enrolment. Stability is defined as no change in medical treatment.
Participants will use the AffloVest for 30 minutes twice dally [in addition to their standard airway clearance regimen] for 6 weeks (days 0 - 42). Clinical review and a serial testing will be completed at day1, day 21 and day 42 (at commencement of intervention, after 3 weeks intervention and after 6 weeks intervention) including high resolution computer tomography (HRCT) at full inspiration and full expiration; spirometry (FEV1 and FVC); and the patient reported outcomes Visual Analogue Scale for ease of sputum clearance (VAS), St George's Respiratory Questionnaire (SGRQ) and Quality of Life -Bronchiectasis (QOL-B).
HRCT imaging will be done at full inspiration and full expiration and scored by two independent expert thoracic radiologists using the validated Brody Scoring System which is sensitive and reproducible.
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
盲法说明
CT scans will be anonymised before being sent to Radiographer to Brody score
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and females 18 years or over
- •Current diagnosis of bronchiectasis
- •Productive of sputum on a daily basis
- •Clinical stability over a 2 week period prior to enrolment
排除标准
- •Cystic fibrosis
- •Severe obstructive airways disease (defined as FEV1 less than 25 percent)
- •Predominant lung disease is not bronchiectasis in the opinion of the investigator (e.g. asthma, Chronic Obstructive Pulmonary Disease (COPD), pulmonary fibrosis)
- •Bronchiectasis in only 1 lobe
- •Currently treated non-tuberculous mycobacterial lung disease
- •Acute congestive cardiac failure
- •Contra-indication or unable to perform HRCT imaging, including pregnancy
- •Contra-indication to using AffloVest including lung malignancy, recent rib fractures, radiological evidence of lung cavitation, and recent significant haemoptysis (in the opinion of the investigator)
- •History of poor adherence to physiotherapy treatment
- •Cognitive or memory problems affecting ability to follow instructions or give informed consent
结局指标
主要结局
High Resolution Computed Tomography (HRCT)
时间窗: 6 weeks
HRCT will be done at full inspiration and full expiration and reviewed by two independent radiographers who will be blinded to timepoint and participant. Radiographers will then use the Brody score to give the scans a score reflecting any changes to sputum volume or otherwise from intervention. Scans will be done and reviewed at baseline, three weeks of intervention and six weeks of intervention
次要结局
- Forced Expiratory Volume at 1 second (FEV1)(6 weeks)
- Visual Analogue Score for ease of sputum expectoration (VAS)(6 weeks)
- Quality of Life in Bronchiectasis questionnaire (QOL-B)(6 weeks)