COPD Exacerbation, COPD
Conditions
Keywords
nebulisation, vibrating mesh nebuliser
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.
Interventions
DEVICEJet Nebuliser
Jet Nebuliser
DEVICEVibrating Mesh Nebuliser
Aerogen Device
Sponsors
Aerogen
NHS Greater Clyde and Glasgow
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BORG Score | 30 minutes post treatment | Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oscillometry | 30 minutes post treatment | Change of Oscillometry data |
| Escalation of Care | During Emergency Department Admission (typically < 4 hours) | Requirement for NIV (non invasive ventilation) / Intubation / further nebulisation |
| Blood Gas | 30 minutes post treatment | Change in blood gases post treatment |
| Completion of Treatment | During Emergency Department Admission (typically < 4 hours) | Time to complete initial nebulisation therapy in ED |
| Staff Satisfaction | During Emergency Department Admission (typically < 4 hours) | Reported ED staff satisfaction from main care giver post treatment. Likert 5 point scale. (0 highly dissatisfied 5 highly satisfied) |
Countries
United Kingdom
Outcome results
None listed