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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD Exacerbation
COPD
Keywords: nebulisation
vibrating mesh nebuliser
Lead sponsor: NHS Greater Clyde and Glasgow
Sponsor class: OTHER
Collaborators: name: Aerogen
First posted: 2019-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomised Controlled Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: BORG Score
timeFrame: 30 minutes post treatment
Secondary outcomes:
measure: Oscillometry
timeFrame: 30 minutes post treatment
measure: Escalation of Care
timeFrame: During Emergency Department Admission (typically < 4 hours)
measure: Blood Gas
timeFrame: 30 minutes post treatment
measure: Completion of Treatment
timeFrame: During Emergency Department Admission (typically < 4 hours)
measure: Staff Satisfaction
timeFrame: During Emergency Department Admission (typically < 4 hours)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Emergency Department Queen Elizabeth University Hospital
state: Scotland
Study officials:
References: