The BRAVE Study: Borg Score Outcomes in Respiratory Compromised Acute Exacerbating COPD Patients Receiving Treatment Via Vibrating Mesh Nebuliser Versus Jet Nebuliser in the Emergency Department
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- BORG Score
研究概览
简要总结
The purpose of this study is to compare clinical outcomes in patients with acute COPD treated with a vibrating mesh nebuliser (VMN) versus a current standard jet nebuliser (JN), in the Emergency Department (ED).
Participants will be those who meet the inclusion criteria and have a primary diagnosis of COPD, and consent to take part in the study. Operators will be clinical staff including doctors and nurses who will be trained in the use of the nebulisers.
Delivery of current treatment standards utilising a VMN compared to a JN will improve symptom scores in patients attending ED with COPD exacerbations.
详细描述
This study is a prospective, single-centre, open, randomised study to improve management of acute COPD exacerbation within the Emergency Department. Adults with severe COPD are randomised into 2 groups: vibrating mesh nebuliser or standard jet nebuliser treatment. Salbutamol (5mg) and Ipratropium (0.5mg) will be administered via Aerogen Ultra via valved mask or a standard jet nebuliser via open face mask/. Two further doses of salbutamol to be delivered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •• Primary presentation with acute exacerbation of COPD
排除标准
- •• Unable to give valid consent
- •Patient unable to speak English
- •Patients where alternative diagnosis cannot be excluded
- •Known or suspected pneumonia, pneumothorax, pneumomediastinum, pulmonary oedema, vocal cord dysfunction, aspirated foreign body
- •Any contraindication to delivering bronchodilators
- •Need for immediate intubation , ventilation or non-invasive ventilation
- •Pregnant or lactating
- •Active palliation considered or expected mortality within 48 hours
- •Known background/ comorbid respiratory disease associated with chronic or variable airflow obstruction (significant goitre, central lung tumour or other central airway pathology, bronchiectasis)
结局指标
主要结局
BORG Score
时间窗: 30 minutes post treatment
Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse)
次要结局
- Oscillometry(30 minutes post treatment)
- Escalation of Care(During Emergency Department Admission (typically < 4 hours))
- Blood Gas(30 minutes post treatment)
- Completion of Treatment(During Emergency Department Admission (typically < 4 hours))
- Staff Satisfaction(During Emergency Department Admission (typically < 4 hours))
研究者
David Lowe
Consultant Emergency Medicine
NHS Greater Clyde and Glasgow