A Randomized Controlled Trial of Bronchodilator Delivery by Vibrating Mesh (VM) Nebuliser Versus Small Volume Nebuliser During an Acute Exacerbation of COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in Forced Vital Capacity (FVC)
研究概览
简要总结
When patients get an attack of COPD, one of the main treatments is regular nebulised medications called bronchodilators. These medications act by opening up the airways allowing patients to breathe easier and to reduce shortness of breath. Newer nebulisers may increase the amount of medication that gets into the lungs compared to the standard nebuliser usually used in hospital. This study is being done to assess whether increasing the amount of medication getting into the lungs using these newer nebulisers will help patients recover from a COPD exacerbation.
详细描述
COPD is a common chronic respiratory disease. It is characterised by repeated episodes of acute worsening of symptoms of cough, wheeze and breathlessness called exacerbations. Exacerbations result in patients having to present to hospital for treatment. In Ireland more than one-fifth of all inpatient hospital days for the treatment of respiratory complaints are for the treatment of COPD. The administration of bronchodilators (medication to open the airway) is a central component of the treatment of COPD exacerbation. In the hospital setting these are most commonly administered via a nebuliser. The standard of care in our institution is the Hudson micromist small volume nebuliser.
However, previous studies have shown that Vibrating mesh (VM) nebulisers result in greater deposition of medication to the lungs compared to small volume nebulisers. In addition they resulted in greater improvements in lung function and breathlessness.
This study will assess the efficacy of the Aerogen Ultra VM nebuliser in a real-world setting. The VM nebuliser is readily available for use in the clinical setting and is used to administer bronchodilator therapy, within the terms of its CE Mark. This nebuliser is already in routine use in hospitals within the Royal College of Surgeons in Ireland (RCSI) hospital group.
Patients hospitalised with an exacerbation of COPD will be recruited. There will be two study groups. Group 1 (VM Group): will receive bronchodilator (salbutamol 2.5mg/ipratropium 0.5mg) by Vibrating Mesh Nebuliser (Aerogen Ultra) with facemask and Group 2 (Standard Hospital Care): will receive bronchodilator by small volume nebuliser (Hudson Micromist) via facemask as per standard care.
Both groups will receive bronchodilator therapy four times a day which has already been prescribed by their medical team, and in accordance with recommended guidelines for treatment of COPD exacerbations. Patients will use the nebuliser for the duration of hospital stay or a maximum of 7 days. Lung function and breathlessness scores will be recorded. The aim of this study is to demonstrate that better medication delivery by VM nebulizer during an exacerbation of COPD will lead to greater bronchodilation, shorter recovery time and reduced hospital length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission with acute exacerbation of COPD within 24 hours of presentation to hospital
- •Confirmed COPD diagnosis (FEV1/FVC <0.70 on spirometry)
- •Willing to participate in the study and provide informed consent
排除标准
- •Admission for reason other than COPD exacerbation e.g. Heart Failure
- •Acute confusion as per clinical team
- •Allergy or contraindication to combined bronchodilator medication
- •Severe respiratory sepsis as evident by temperature >38 degrees and/or lobar pneumonia on Chest Radiograph
- •Sustained tachycardia >120bpm
- •Patients with very advanced COPD, admitted for palliative or long term care
- •Patients re-admitted within 90 days who have already been enrolled in the study.
研究组 & 干预措施
Vibrating Mesh Group
Patient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Aerogen Ultra (CE 0050) vibrating mesh Nebuliser.
干预措施: Vibrating Mesh Nebuliser (Device)
Standard Hospital Care Group
Patient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Hudson micromist small volume nebuliser which is the standard of care at our institution.
干预措施: Standard Hospital Care (Device)
结局指标
主要结局
Change in Forced Vital Capacity (FVC)
时间窗: Up to 7 days
Forced spirometry measured at bedside
次要结局
- Personal Satisfaction Score(Up to 7 days)
- Time to re-exacerbation .(Up to 30 days)
- Change in quality of life (QOL): to discharge and to Day 30(Up to 30 days)
- Change in Borg breathlessness score(Up to 7 days)
- Length of Hospital Stay(Up to 7 days)
- Change in Inspiratory Capacity (IC)(Up to 7 days)
- Rate of re-exacerbation at Day 30(Up to 30 days)
- Change in Forced Expiratory Volume in one second (FEV1)(Up to 7 days)
研究者
Professor Richard Costello
Consultant Respiratory Physician
Beaumont Hospital