Symptomatic Treatment of Excessive Dynamic Airway Collapse Using Daytime Portable Continuous Positive Airway Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Does daytime activity by an accelerometer change from baseline to 4 weeks
研究概览
简要总结
The aim of this study is to assess the benefit of a portable ventilator generating positive end-expiratory pressure on exercise tolerance in patients with Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM).
详细描述
Excessive dynamic airway collapse (EDAC) and tracheobronchomalacia (TBM) occur due to abnormal weakening of the walls of the central airways leading to central airway collapse on expiration. This collapse is responsible for breathlessness, cough or syncope. In adults, this weakening can be idiopathic (Mounier-Khun syndrome), secondary to respiratory diseases such as chronic obstructive pulmonary disease (COPD), secondary to systemic diseases such as relapsing polychondritis (RP) or secondary to invasive ventilation or trauma. The incidence of EDAC and TBM varies from 12% in all patients undergoing bronchoscopy to 44% in patients with chronic bronchitis undergoing bronchoscopy. Gold standard for the diagnosis of EDAC and TBM is bronchoscopy which identifies and quantifies the narrowing of the airway. Non-invasive technique such as inspiratory and expiratory chest computed-tomography (CT) can also be used to diagnose EDAC / TBM.
Currently, in addition to management of the underlying disease, treatment options for EDAC / TBM are limited. Surgical tracheoplasty can be offered but can be associated with severe post-operative complications. Airway stenting can also be offered but, even if this treatment improved quality of life, it fails to improve exercise capacity. Airway stenting is also associated with infectious complications as well as stent migrations. Other endoscopic treatment such as Yttrium Aluminium Perovskite laser can be offered with good results but have not yet been validated in a randomised trial. Nocturnal non-invasive ventilation (NIV) can also be used, especially in patients with associated obstructive sleep apnoeas but again there is not randomised clinical trial evidence that validates this approach in adults. Expiratory Positive Airway Pressure (EPAP) provides a pneumatic stenting that prevents the expiratory collapse of the airway. But, by giving the NIV during the night, patients are left without any support during the day whilst their respiratory demand is higher and when they are more symptomatic. Currently, NIV is only given at night or at rest because current non-invasive ventilators are not suitable for ambulatory use as they are heavy. Recently, a new portable ventilator with built-in battery has been issued (Z1®, Breas®). This ventilator is light (500g) portable and has a working duration of 8 hours. Therefore, it can be easily carried and used while walking. By providing a nasal pillow interface (Nasal swift®, Resmed®) to patients, it will allow them to walk safely with the device on.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with diagnosed EDAC or TBM on inspiratory/expiratory CT or bronchoscopy
- •Patient with exertional dyspnea
排除标准
- •Pregnancy
- •Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
- •Inability to perform 6-MWT
- •Current intra-tracheal stent
- •Previous surgery for EDAC or TBM
- •Uncontrolled underlying disease:
- •Initiation of home mechanical ventilation in last 3 months
- •Uncontrolled joint pain
研究组 & 干预措施
Run In Phase
Eligible patients will have 6-Minute Walk Test (6-MWT) on self ventilation and on CPAP
干预措施: Experimental: Run In Phase (Other)
Treatment
Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either:
Treatment arm - Patients will be setup onto portable CPAP during the day
干预措施: Experimental: Treatment (Other)
Standard Care Arm
Those patients who improve their 6-MWT by more than 30 meters will then be randomised to either:
Control Arm - Standard care arm.
干预措施: Sham Comparator: Stand Care Arm (Other)
结局指标
主要结局
Does daytime activity by an accelerometer change from baseline to 4 weeks
时间窗: 4 weeks
Daytime activity assessed by an accelerometer. Participants will be assessed at baseline and at 4 weeks in the control arm and in the treatment arm with participants on portable CPAP to see if there is any change between the time frames and between the groups on daytime activity measured by accelerometers that all participants randomised into the trial will wear from baseline to follow up at 4 weeks.
次要结局
- Distance in 6-MWT on Continous Positive Airway Pressure (CPAP) at 4 weeks follow-up(4 weeks)
- Change in respiratory-related quality of life - Severe Respiratory Insufficiency (SRI)(4 weeks)
- Change in respiratory-related quality of life - St George's Respiratory Questionnaire (SGRQ)(4 weeks)
- Change in neural respiratory drive with parasternal electromyography(4 weeks)
- Change of lung homogeneity assessed by electrical impedance tomography while on CPAP(4 weeks)
- Change in cross-sectional area quadriceps rectus femoris ultra-sound(4 weeks)
