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.
Studieöversikt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Studietyp
Inskrivning (Beräknad)
Inskrivning
Kontakter och platser
Studiekontakt
Studiekontakt
- Namn: Professor Tom M Wilkinson, MBBS PhD FRCP FERS
- Telefonnummer: 02381205341
- E-post: t.wilkinson@soton.ac.uk
Studera Kontakt Backup
- Namn: Madison E Geeves, MSc BSc
- E-post: m.e.geeves@soton.ac.uk
Studieorter
-
-
Hampshire
-
Andover, Hampshire, Storbritannien, SP10 3LB
- Hampshire Hospitals NHS Foundation Trust
-
Huvudutredare:
- Harry S Griffin, PhD HCPC
-
Southampton, Hampshire, Storbritannien, SO16 6YD
- University Hospital Southampton NHS Foundation Trust
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-
Deltagandekriterier
Urvalskriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Antal grupper/kohorter
Kohorter och interventioner
Grupp / KohortGrupp / Kohort |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
GP direct access spirometry within community diagnostic centres
Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres
|
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.
|
Vad mäter studien?
Primära resultatmått
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
Tidsram: Baseline
|
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
|
Baseline
|
Sekundära resultatmått
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Diagnostic accuracy of oscillometry
Tidsram: Baseline
|
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
|
Baseline
|
|
Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions
Tidsram: 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
|
Baseline
|
|
Feasibility outcomes in Lung Cancer Screening pathway
Tidsram: 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
Tidsram: Baseline
|
Time per test of advanced diagnostic technologies compared to usual care
|
Baseline
|
|
Comparative 'failure rate'
Tidsram: Baseline
|
Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
|
Baseline
|
|
Usability and acceptability
Tidsram: Baseline
|
Patients' perceptions on the usability and acceptability of advanced respiratory diagnostic technologies compared to existing tests such as spirometry via a non-validated questionnaire
|
Baseline
|
|
Usability and acceptability
Tidsram: Baseline
|
Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies via semi-structured interviews
|
Baseline
|
Samarbetspartners och utredare
Sponsor
Sponsor
Samarbetspartners
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Studiestart
Primärt slutförande (Beräknad)
Primärt slutförande
Avslutad studie (Beräknad)
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Första postat
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste uppdatering publicerad
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Luftvägssjukdomar
- Lungsjukdomar
- Lungsjukdomar, obstruktiv
- Patologiska tillstånd, tecken och symtom
- Lungsjukdom, kronisk obstruktiv
- Diagnostiska tekniker och procedurer
- Diagnos
- Diagnostiska tekniker, andningssystem
- Andningsfunktionstester
- Spirometri
- Kapnografi
Andra studie-ID-nummer
Andra studie-ID-nummer
- DEV DVB0067
- 359125 (Annan identifierare: IRAS Number)
- RHM RSP0030 (Annan identifierare: Local Reference Number)
- 25/NE/0225 (Annan identifierare: REC ID)
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Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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