Capnography
Diagnostic TestCapnography used in combination with machine learning-derived algorithms, with or without reversibility testing (if indicated on spirometry)
NCT Number: NCT07798596
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Hampshire Hospitals NHS Foundation Trust, Andover, Hampshire, United Kingdom
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Spirometry, with or without reversibility testing
Time frame: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Time frame: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Time frame: Baseline
Time per test of advanced diagnostic technologies compared to usual care
Time frame: Baseline
Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
Time frame: Baseline
Patients' perceptions on the usability and acceptability of advanced respiratory diagnostic technologies compared to existing tests such as spirometry. Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies, and barriers and facilitators to their adoption.
Time frame: Baseline
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
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
Contact information is provided by the study sponsor or research team.
Madison E Geeves, MSc BSc
CONTACT
Professor Tom M Wilkinson, MBBS PhD FRCP FERS
CONTACT
University Hospital Southampton NHS Foundation Trust
Other
BREATHE: Benchmarking Respiratory Evaluation of Advanced Technologies for Healthcare Excellence
Acronym: BREATHE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07780630
Asthma, Asthma (Diagnosis)
Pessac, France
View Trial DetailsNCT07749001
COPD (Chronic Obstructive Pulmonary Disease), Chronic Disease
View Trial DetailsNCT07751003
Acute Exacerbation of COPD, COPD (Chronic Obstructive Pulmonary Disease)
Zhengzhou, Henan, China
View Trial DetailsNCT07719192
COPD (Chronic Obstructive Pulmonary Disease), Chronic Disease
Lahore, Punjab Province, Pakistan
View Trial Details