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

NCT04181073 | Unknown

• 1 other identifier: GN17RM666
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation; COPD

Keywords

nebulisation; vibrating mesh nebuliser

Outcome Measures

Primary Outcomes (1)

• BORG Score

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

  30 minutes post treatment

Secondary Outcomes (5)

• Oscillometry

  30 minutes post treatment

• Escalation of Care

  During Emergency Department Admission (typically < 4 hours)

• Blood Gas

  30 minutes post treatment

• Completion of Treatment

  During Emergency Department Admission (typically < 4 hours)

• Staff Satisfaction

  During Emergency Department Admission (typically < 4 hours)

Study Arms (2)

Jet Nebuliser

ACTIVE COMPARATOR

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

Device: Jet Nebuliser

Vibrating Mesh Nebuliser

EXPERIMENTAL

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

Device: Vibrating Mesh Nebuliser

Interventions

Jet Nebuliser DEVICE

Jet Nebuliser

Jet Nebuliser

Vibrating Mesh Nebuliser DEVICE

Aerogen Device

Vibrating Mesh Nebuliser

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary presentation with acute exacerbation of COPD

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Clyde and Glasgow: lead
• Aerogen: collaborator

Study Sites (1)

Emergency Department Queen Elizabeth University Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Emergency Medicine

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: November 23, 2019
• First Posted: November 29, 2019
• Study Start: July 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months
• Access Criteria: Via Safe Haven Committee

Locations

GB (1)