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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COPD Exacerbation COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomised Controlled Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Jet Nebuliser

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

Group Type ACTIVE_COMPARATOR

Jet Nebuliser

Intervention Type DEVICE

Jet 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

Group Type EXPERIMENTAL

Vibrating Mesh Nebuliser

Intervention Type DEVICE

Aerogen Device

Interventions

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Jet Nebuliser

Intervention Type DEVICE

Vibrating Mesh Nebuliser

Aerogen Device

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No