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)

May 16, 2020 updated by: David Lowe, NHS Greater Clyde and Glasgow

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

Unknown

Conditions

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Recruiting
        • Emergency Department Queen Elizabeth University Hospital
        • Contact:
        • Sub-Investigator:
          • Claire McGroarty, MBChB
        • Sub-Investigator:
          • Chris Carlin, MBChB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

November 23, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 16, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN17RM666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be stored in Safe Haven GG&C

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Via Safe Haven Committee

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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