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| Name | Class |
|---|---|
| Aerogen | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jet Nebuliser | Active Comparator | Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Jet Nebuliser |
|
| Vibrating Mesh Nebuliser | Experimental | Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Vibrating Mesh Nebuliser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jet Nebuliser | Device | Jet Nebuliser |
| |
| Vibrating Mesh Nebuliser |
| Measure | Description | Time Frame |
|---|---|---|
| BORG Score | Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse) | 30 minutes post treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Unable to give valid consent
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department Queen Elizabeth University Hospital | Recruiting | Glasgow | Scotland | G51 4TF | United Kingdom |
Data will be stored in Safe Haven GG&C
6 months
Via Safe Haven Committee
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Randomised Controlled Trial
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| Device |
Aerogen Device |
|
| 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) |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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