Comparing Advanced Technologies to Standard Testing for the Diagnosis of Airway Disease in Hospital and Community Settings (BREATHE)
BREATHE: Benchmarking Respiratory Evaluation of Advanced Technologies for Healthcare Excellence
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.
Study Overview
Status
Detailed Description
Long-term lung conditions such as COPD affect around one in five people and are the third leading cause of death in England. These conditions are often not picked up until they have reached an advanced stage, and sometimes people are given an incorrect diagnosis. They cause breathing difficulties due to lung damage, which cannot be reversed in the case of COPD.
At present, lung conditions are usually diagnosed through breathing tests like spirometry. These tests require people to blow forcefully into a machine several times, which can be uncomfortable and difficult for some patients. They also rely on specialist equipment and must be carried out and interpreted by highly trained professionals. Because there aren't enough of these professionals, waiting lists can be long. Even when spirometry is possible, it does not always detect lung disease early.
Two national NHS programmes - the Community Diagnostic Centre (CDC) programme and the Lung Cancer Screening (LCS) programme - create opportunities to find lung disease earlier. However, the same challenges with spirometry remain.
Recently, new types of lung tests have been developed. These tests may be simpler, quicker, and cheaper to use, but they are not yet part of standard NHS care. We need to find out whether these new tests can identify lung disease as well as, or better than, spirometry, especially at earlier stages. If they can, they may help prevent further lung damage and improve health outcomes. It is also important to understand how practical and cost-effective these tests are, and whether they could be used widely in different healthcare settings.
To explore this, we will carry out the new tests alongside traditional lung function tests in both community and hospital settings. We will invite adults with possible COPD who:
- have been referred for spirometry at local CDCs,
- have been referred for lung function testing at secondary care hospitals,
- are attending for a lung scan as part of the LCS pathway, and
- are attending local community groups or events.
Participants may also be asked to complete short surveys or optional interviews to share their experiences. Healthcare professionals working in testing centres will be invited to do the same. We are especially keen to hear from people who live with lung conditions or who experience health inequalities, so that we can understand how easy the tests are to use, how comfortable they are, and whether they could work well across different healthcare settings.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Professor Tom M Wilkinson, MBBS PhD FRCP FERS
- Phone Number: 02381205341
- Email: t.wilkinson@soton.ac.uk
Study Contact Backup
- Name: Madison E Geeves, MSc BSc
- Email: m.e.geeves@soton.ac.uk
Study Locations
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Hampshire
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Andover, Hampshire, United Kingdom, SP10 3LB
- Hampshire Hospitals NHS Foundation Trust
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Principal Investigator:
- Harry S Griffin, PhD HCPC
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Southampton, Hampshire, United Kingdom, SO16 6YD
- University Hospital Southampton NHS foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 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
- Able to fully understand and cooperate with the study protocol
- Clinically stable with no contraindications to lung function testing (outlined below)
Exclusion Criteria:
- Confirmed diagnosis of COPD
- Not willing and/or able to provide fully informed written consent to participate
- Has a relative contraindication to lung function testing [18]:
- Recent thoracic, abdominal or eye (e.g. cataract) surgery < 6 weeks
- Unstable cardiovascular status, including recent myocardial infarction or pulmonary embolus < 6 weeks
- Pneumothorax < 6 weeks
- Haemoptysis of unknown origin < 6 weeks
- Thoracic, abdominal or cerebral aneurysm
- Chest infection < 6 weeks
- An acute illness or symptom that might interfere with test performance (e.g. nausea, vomiting).
- The presence of any other clinical condition that would prevent the individual from safely performing lung function tests
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
GP direct access spirometry within community diagnostic centres
Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres
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Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry).
Measures respiratory impedance during normal tidal breathing.
Fractional exhaled nitric oxide (if requested).
Used to assess airway inflammation.
Spirometry, with or without reversibility testing
|
|
Full lung function testing within secondary care hospitals
Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals
|
Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry).
Measures respiratory impedance during normal tidal breathing.
Fractional exhaled nitric oxide (if requested).
Used to assess airway inflammation.
Spirometry, with or without reversibility testing
Assesses lung diffusing capacity, performed using full pulmonary function testing equipment
Body plethysmography (if applicable).
Used to assess static lung volumes and, where applicable, specific resistance, performed using full lung function equipment
|
|
Low dose-CT scan within lung cancer screening programme
Adults with suspected COPD/airway disease attending for a low-dose CT scan as part of the lung cancer screening programme
|
Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry).
Measures respiratory impedance during normal tidal breathing.
|
|
Community outreach
Adults with suspected COPD/airway disease attending local community groups and events
|
Capnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
Oscillometry (where applicable), with or without reversibility testing (if indicated on spirometry).
Measures respiratory impedance during normal tidal breathing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
Time Frame: Baseline
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Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of oscillometry
Time Frame: Baseline
|
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
|
Baseline
|
|
Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions
Time Frame: Baseline
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Identification of pre-COPD using advanced respiratory diagnostic technologies in patients with normal forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC) ratio on spirometry but signs of reduced FEV1, gas trapping, hyperinflation, or reduced diffusing capacity on additional lung function tests performed in secondary care, or emphysema on CT scan.
Differentiation of COPD from asthma using advanced diagnostic tests, particularly in patients presenting with overlapping respiratory symptoms
|
Baseline
|
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Feasibility outcomes in Lung Cancer Screening pathway
Time Frame: Baseline
|
Recruitment uptake rate, time required and the acceptability to both patients and healthcare professional to complete additional diagnostic testing in individuals invited for low-dose CT (LDCT) as part of the lung cancer screening (LCS) pathway
|
Baseline
|
|
Time per test
Time Frame: Baseline
|
Time per test of advanced diagnostic technologies compared to usual care
|
Baseline
|
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Comparative 'failure rate'
Time Frame: Baseline
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Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
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Baseline
|
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Usability and acceptability
Time Frame: Baseline
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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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Baseline
|
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Usability and acceptability
Time Frame: Baseline
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Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies via semi-structured interviews
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Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pathological Conditions, Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Techniques, Respiratory System
- Respiratory Function Tests
- Spirometry
- Capnography
Other Study ID Numbers
- DEV DVB0067
- 359125 (Other Identifier: IRAS Number)
- RHM RSP0030 (Other Identifier: Local Reference Number)
- 25/NE/0225 (Other Identifier: REC ID)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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