The Breathe Easy study: Mask On, Mask Off (MoMo) sub study for diagnosis of respiratory illness

Not Applicable

Completed

• Conditions: Pneumonia; Asthma; Chronic Obstructive Pulmonary Disease (COPD); Lower respiratory tract disease; Respiratory - Asthma; Respiratory - Chronic obstructive pulmonary disease; Respiratory - Other respiratory disorders / diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12621001086853
• Lead Sponsor: Paul Porter

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-17
• Study Completion: 2022-06-30
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

Any adolescent or adult over 12 years of age presenting to low acuity ambulatory care units, respiratory medicine clinics, the ED or admitted to the ward of a participating institution with a diagnosis of asthma, COPD, pneumonia, or lower respiratory disease.

Exclusion Criteria

Lack of a signed consent form
Need for ventilatory support (including non-invasive means such as CPAP, high flow nasal oxygen, BiPAP),
Terminal disease.
Medical contraindication to voluntary cough, including severe respiratory distress, history of pneumothorax, eye, chest or abdominal surgery within the past 3 months
Too medically unstable to participate in study as per attending clinician.
Structural airway disease including laryngomalacia or tracheomalacia.
Acute Heart failure
Neuromuscular disease
Lobectomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the measures of agreement between the algorithm result obtained with a mask to clinical diagnosis.. As a clinical diagnosis is a non-reference standard, Postive and negative percent agreement will be determined rather than sensitivity and specificity.[Codes will be generated immediately but only unblinded at the end of the study]

Secondary Outcome Measures

Name	Time	Method
A secondary outcome is the measures of agreement between the algorithm result obtained without a mask to clinical diagnosis.. As a clinical diagnosis is a non-reference standard, Postive and negative percent agreement will be determined rather than sensitivity and specificity.[Codes will be generated immediately but only unblinded at the end of the study];A secondary outcome is the measures of agreement between the algorithm result obtained with a mask to the algorithm result without a mask.. Sensitivity and specificity will be the measures used to analyse the data.[Codes will be generated immediately but only unblinded at the end of the study.<br><br>]