Airway disease, such as chronic obstructive pulmonary disease (COPD), is usually diagnosed through breathing tests like spirometry. However, it requires people to blow forcefully into a machine several times which can be uncomfortable and difficult for some patients.
This study is looking at whether newer technologies and other breathing tests can help diagnose COPD as accurately as standard testing. We will compare these tests in both hospital and community settings. We are interested in understanding how practical and cost-effective these tests are, including how easy they are to use and how comfortable they are for patients to perform.
≥ 18 years of age
New referral to community or secondary healthcare services
Clinical suspicion of airway disease/COPD
Able to provide fully informed written consent
Confirmed diagnosis of COPD
Not willing and/or able to provide fully informed written consent to participate
Recent thoracic, abdominal or eye (e.g. cataract) surgery < 6 weeks
Unstable cardiovascular status, including recent myocardial infarction or pulmonary embolus < 6 weeks
Adults with a clinical suspicion of COPD/airway disease referred for spirometry testing at local community diagnostic centres or for lung function testing at secondary care hospitals. Additionally, adults attending for a low-dose CT scan as part of the lung cancer screening programme or adults attending local community groups or events
Cohort
Prospective
Capnography
Diagnostic testCapnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry
Diagnostic testOscillometry (where applicable), with or without reversibility testing (if indicated on spirometry). Measures respiratory impedance during normal tidal breathing.
FENO
Diagnostic testFractional exhaled nitric oxide (if requested). Used to assess airway inflammation.
Gas Transfer
Diagnostic testAssesses lung diffusing capacity, performed using full pulmonary function testing equipment
Static Lung Volumes
Diagnostic testBody plethysmography (if applicable). Used to assess static lung volumes and, where applicable, specific resistance, performed using full lung function equipment
Spirometry
Diagnostic testSpirometry, with or without reversibility testing
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Diagnostic accuracy of oscillometry
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Time per test
Time per test of advanced diagnostic technologies compared to usual care
Comparative 'failure rate'
Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
Usability and acceptability
Patients' perceptions on the usability and acceptability of advanced respiratory diagnostic technologies compared to existing tests such as spirometry via a non-validated questionnaire
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University Hospital Southampton NHS Foundation Trust
Lead sponsor
Hampshire Hospitals NHS Foundation Trust
Collaborator
University of Southampton
Collaborator
TidalSense
Collaborator
NIHR Southampton Respiratory Biomedical Research Centre
Collaborator
Restech Srl
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
