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

Not Applicable

• Conditions: COPD; COPD Exacerbation
• Interventions: Device: Vibrating Mesh Nebuliser; Device: Jet Nebuliser

• Registration Number: NCT04181073
• Lead Sponsor: NHS Greater Clyde and Glasgow

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-11-23
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-16
• Last Update Posted: 2020-05-19
• Primary Completion: 2021-06
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
BORG Score	30 minutes post treatment	Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse)

Secondary Outcome Measures

Name	Time	Method
Completion of Treatment	During Emergency Department Admission (typically < 4 hours)	Time to complete initial nebulisation therapy in ED
Staff Satisfaction	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)
Oscillometry	30 minutes post treatment	Change of Oscillometry data
Escalation of Care	During Emergency Department Admission (typically < 4 hours)	Requirement for NIV (non invasive ventilation) / Intubation / further nebulisation
Blood Gas	30 minutes post treatment	Change in blood gases post treatment

Trial Locations

Locations (1)

Emergency Department Queen Elizabeth University Hospital; 🇬🇧 Glasgow, Scotland, United Kingdom