Borg Score Outcomes in Respiratory Compromised Acute Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients Receiving Treatment Via Vibrating Mesh Nebuliser Versus Jet Nebuliser in the Emergency Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COPD Exacerbation, COPD

Intervention / Treatment
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* Device: Jet Nebuliser
* Device: Vibrating Mesh Nebuliser


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomised Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Jet Nebuliser<br>Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Jet Nebuliser | Device: Jet Nebuliser<br>* Jet Nebuliser<br>|
| Experimental: Vibrating Mesh Nebuliser<br>Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Vibrating Mesh Nebuliser | Device: Vibrating Mesh Nebuliser<br>* Aerogen Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BORG Score | Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse) | 30 minutes post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oscillometry | Change of Oscillometry data | 30 minutes post treatment | 
| Escalation of Care | Requirement for NIV (non invasive ventilation) / Intubation / further nebulisation | During Emergency Department Admission (typically < 4 hours) | 
| Blood Gas | Change in blood gases post treatment | 30 minutes post treatment | 
| Completion of Treatment | Time to complete initial nebulisation therapy in ED | During Emergency Department Admission (typically < 4 hours) | 
| Staff Satisfaction | Reported ED staff satisfaction from main care giver post treatment. Likert 5 point scale. (0 highly dissatisfied 5 highly satisfied) | During Emergency Department Admission (typically < 4 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nebulisation, vibrating mesh nebuliser