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)

NHS Greater Clyde and Glasgow

Status

Unknown

Conditions

COPD

COPD Exacerbation

Treatments

Device: Vibrating Mesh Nebuliser

Device: Jet Nebuliser

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04181073

GN17RM666

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)