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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)

Primary Purpose

COPD Exacerbation, COPD

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Jet Nebuliser
Vibrating Mesh Nebuliser
Sponsored by
NHS Greater Clyde and Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD Exacerbation focused on measuring nebulisation, vibrating mesh nebuliser

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Emergency Department Queen Elizabeth University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Jet Nebuliser

Vibrating Mesh Nebuliser

Arm Description

Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Jet Nebuliser

Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Vibrating Mesh Nebuliser

Outcomes

Primary Outcome Measures

BORG Score
Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse)

Secondary Outcome Measures

Oscillometry
Change of Oscillometry data
Escalation of Care
Requirement for NIV (non invasive ventilation) / Intubation / further nebulisation
Blood Gas
Change in blood gases post treatment
Completion of Treatment
Time to complete initial nebulisation therapy in ED
Staff Satisfaction
Reported ED staff satisfaction from main care giver post treatment. Likert 5 point scale. (0 highly dissatisfied 5 highly satisfied)

Full Information

First Posted
November 23, 2019
Last Updated
May 16, 2020
Sponsor
NHS Greater Clyde and Glasgow
Collaborators
Aerogen
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1. Study Identification

Unique Protocol Identification Number
NCT04181073
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Greater Clyde and Glasgow
Collaborators
Aerogen

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation, COPD
Keywords
nebulisation, vibrating mesh nebuliser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Randomised Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jet Nebuliser
Arm Type
Active Comparator
Arm Description
Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Jet Nebuliser
Arm Title
Vibrating Mesh Nebuliser
Arm Type
Experimental
Arm Description
Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Vibrating Mesh Nebuliser
Intervention Type
Device
Intervention Name(s)
Jet Nebuliser
Intervention Description
Jet Nebuliser
Intervention Type
Device
Intervention Name(s)
Vibrating Mesh Nebuliser
Intervention Description
Aerogen Device
Primary Outcome Measure Information:
Title
BORG Score
Description
Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse)
Time Frame
30 minutes post treatment
Secondary Outcome Measure Information:
Title
Oscillometry
Description
Change of Oscillometry data
Time Frame
30 minutes post treatment
Title
Escalation of Care
Description
Requirement for NIV (non invasive ventilation) / Intubation / further nebulisation
Time Frame
During Emergency Department Admission (typically < 4 hours)
Title
Blood Gas
Description
Change in blood gases post treatment
Time Frame
30 minutes post treatment
Title
Completion of Treatment
Description
Time to complete initial nebulisation therapy in ED
Time Frame
During Emergency Department Admission (typically < 4 hours)
Title
Staff Satisfaction
Description
Reported ED staff satisfaction from main care giver post treatment. Likert 5 point scale. (0 highly dissatisfied 5 highly satisfied)
Time Frame
During Emergency Department Admission (typically < 4 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Emergency Department Queen Elizabeth University Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David J Lowe, MBChB
Phone
0141 232 7600
Email
Glasgow.CRF@ggc.scot.nhs.uk
First Name & Middle Initial & Last Name & Degree
Claire McGroarty, MBChB
First Name & Middle Initial & Last Name & Degree
Chris Carlin, MBChB

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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