The Role of Humidified Nasal High-flow to Reduce 30-day Hospital Re-admissions Following Severe Exacerbations of Chronic Obstructive Pulmonary Disease: a Mixed Methods Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time to 30-day hospital readmission following index hospitalisation with AECOPD
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million people in the United Kingdom (UK). COPD patients suffer with episodes of worsening breathing symptoms called acute exacerbations (AECOPD). Exacerbations occur more often as the disease progresses and are a leading cause of emergency hospitalisation. Patients recovering from exacerbations are at high risk of deteriorating, with one quarter readmitted to hospital within thirty days. COPD thus imposes immense burdens on the National Health Service and patients.
This research will investigate the effects of using humidified nasal high-flow (HNHF) during recovery from severe COPD exacerbations. HNHF delivers warmed, humidified air under flows of up to 60 litres per minute through a nasal interface. This has been shown to improve clinical outcomes, including exacerbation frequency, hospitalisations, breathlessness and quality of life amongst COPD patients with respiratory failure. It is thought to achieve this by improving secretion clearance and providing positive airways pressure which supports the breathing system.
Patients admitted to St Thomas' Hospital, London with COPD exacerbations will be recruited. Prior to discharge, participants will be randomised to receive either usual care alone or usual care plus a HNHF device, which they will be trained to use for a regular period daily. Usual care includes inhalers, steroids and may include antibiotics.
Participants will be followed up for 30-days after hospital discharge using weekly assessments, daily symptom diaries and wrist-worn watch-like devices that detect physical activity. This will enable evaluation of the clinical effects of HNHF on re-exacerbations, readmissions, breathlessness, physical activity and quality of life. Device usage will also be quantified. Participants who receive devices will be interviewed to explore their experiences. After the 30-day home follow-up period, a sub-group of participants will undergo detailed breathing tests during and after exercise to explore the effects of HNHF on the respiratory system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency hospital admission with a primary diagnosis of AECOPD
- •Aged 40-80 years
- •≥10 pack year smoking history
- •Body mass index ≤ 35kg/m2
- •Cognitively and linguistically able to follow English instructions, provide informed consent and complete the study protocol
- •To be discharged home following the hospitalisation in a home environment deemed safe by the investigator to perform home assessments
- •Patient lives in the catchment area served by the Integrated Respiratory Team at Guy's and St Thomas' NHS Foundation Trust
排除标准
- •Chest radiograph excludes pneumothorax
- •Requirement for acute non-invasive ventilation (NIV) during index hospitalisation or established on home positive airway pressure (PAP)
- •Significant chronic respiratory failure (PaCO2 >7.0)
- •Clinically significant obstructive sleep apnoea requiring treatment
- •Allergies to latex, metals or local anaesthetic
- •Broken or inflamed skin at the second intercostal space parasternal chest wall areas
- •Psychological or social factors that would impair compliance with the study protocol
- •Any major non-COPD chronic co-morbidity that may contribute significantly to risk of readmission, including (but not limited to) severe heart failure (left ventricular ejection fraction <30%), malignancy (active treatment or palliation), end stage renal failure and significant neuromuscular disease
- •Planned travel away from home in the 30-day post-discharge period
结局指标
主要结局
Time to 30-day hospital readmission following index hospitalisation with AECOPD
时间窗: 30 days following hospital discharge
30-day readmission
次要结局
- Adherence with completion of clinical outcome measures (symptom diary)(30 days following hospital discharge)
- Health-related quality of life: COPD Assessment Test(30 days following hospital discharge)
- Health-related quality of life: Clinical COPD Questionnaire(30 days following hospital discharge)
- Neural respiratory drive(30 days following hospital discharge)
- Pulmonary pressures and flow(30 days following hospital discharge)
- Recruitment rate of eligible patients(30 days following hospital discharge)
- Adherence with completion of clinical outcome measures (physical activity monitor)(30 days following hospital discharge)
- Acceptability of HNHF at home: semi-structured interviews(30 days following hospital discharge)
- Physical activity(30 days following hospital discharge)
- Participants' HNHF device usage(30 days following hospital discharge)
- Time to recover from maximal breathlessness(30 days following hospital discharge)
- Adherence with completion of clinical outcome measures (spirometry)(30 days following hospital discharge)
- Non-readmission AECOPD(30 days following hospital discharge)
- Inspiratory capacity(30 days following hospital discharge)
- Breathlessness(30 days following hospital discharge)