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

COPD Clinical Trial

— BRAVE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04181073
• Other study ID #: GN17RM666
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: October 2021

Study information

• Verified date: May 2020
• Source: NHS Greater Clyde and Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Emergencies

Intervention

Device:
• Jet Nebuliser
Jet Nebuliser
• Vibrating Mesh Nebuliser
Aerogen Device

Locations

Country	Name	City	State
United Kingdom	Emergency Department Queen Elizabeth University Hospital	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Clyde and Glasgow	Aerogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BORG Score	Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse)	30 minutes post treatment
Secondary	Oscillometry	Change of Oscillometry data	30 minutes post treatment
Secondary	Escalation of Care	Requirement for NIV (non invasive ventilation) / Intubation / further nebulisation	During Emergency Department Admission (typically < 4 hours)
Secondary	Blood Gas	Change in blood gases post treatment	30 minutes post treatment
Secondary	Completion of Treatment	Time to complete initial nebulisation therapy in ED	During Emergency Department Admission (typically < 4 hours)
Secondary	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)