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
Overview
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- BORG Score
Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• Primary presentation with acute exacerbation of COPD
Exclusion Criteria
- •• 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)
Outcomes
Primary Outcomes
BORG Score
Time Frame: 30 minutes post treatment
Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse)
Secondary Outcomes
- 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))
Investigators
David Lowe
Consultant Emergency Medicine
NHS Greater Clyde and Glasgow