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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: NHS Greater Clyde and Glasgow · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD Exacerbation
• COPD

Interventions

Type	Name	Description
DEVICE	Jet Nebuliser	Jet Nebuliser
DEVICE	Vibrating Mesh Nebuliser	Aerogen Device

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-06-01
• Completion: 2021-10-01
• First posted: 2019-11-29
• Last updated: 2020-05-19

Locations

1 site across 1 country: United Kingdom