- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04181073
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 (BRAVE)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Scotland
-
Glasgow, Scotland, United Kingdom, G51 4TF
- Recruiting
- Emergency Department Queen Elizabeth University Hospital
-
Contact:
- David J Lowe, MBChB
- Phone Number: 0141 232 7600
- Email: Glasgow.CRF@ggc.scot.nhs.uk
-
Sub-Investigator:
- Claire McGroarty, MBChB
-
Sub-Investigator:
- Chris Carlin, MBChB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Jet Nebuliser
Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Jet Nebuliser
|
Jet Nebuliser
|
Experimental: Vibrating Mesh Nebuliser
Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Vibrating Mesh Nebuliser
|
Aerogen Device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BORG Score
Time Frame: 30 minutes post treatment
|
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
Time Frame: 30 minutes post treatment
|
Change of Oscillometry data
|
30 minutes post treatment
|
Escalation of Care
Time Frame: During Emergency Department Admission (typically < 4 hours)
|
Requirement for NIV (non invasive ventilation) / Intubation / further nebulisation
|
During Emergency Department Admission (typically < 4 hours)
|
Blood Gas
Time Frame: 30 minutes post treatment
|
Change in blood gases post treatment
|
30 minutes post treatment
|
Completion of Treatment
Time Frame: During Emergency Department Admission (typically < 4 hours)
|
Time to complete initial nebulisation therapy in ED
|
During Emergency Department Admission (typically < 4 hours)
|
Staff Satisfaction
Time Frame: 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)
|
During Emergency Department Admission (typically < 4 hours)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN17RM666
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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