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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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

관찰

등록 (추정된)

300

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Professor Tom M Wilkinson, MBBS PhD FRCP FERS
  • 전화번호: 02381205341
  • 이메일: t.wilkinson@soton.ac.uk

연구 연락처 백업

연구 장소

    • Hampshire
      • Andover, Hampshire, 영국, SP10 3LB
        • Hampshire Hospitals NHS Foundation Trust
        • 수석 연구원:
          • Harry S Griffin, PhD HCPC
      • Southampton, Hampshire, 영국, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms
기간: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Baseline

2차 결과 측정

결과 측정
측정값 설명
기간
Diagnostic accuracy of oscillometry
기간: Baseline
Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD
Baseline
Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions
기간: 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
기간: 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
기간: Baseline
Time per test of advanced diagnostic technologies compared to usual care
Baseline
Comparative 'failure rate'
기간: Baseline
Comparative 'failure rate' of advanced diagnostic technologies compared to usual care
Baseline
Usability and acceptability
기간: 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
기간: Baseline
Healthcare practitioners' perceptions on the usability, acceptability and confidence in advanced respiratory diagnostic technologies via semi-structured interviews
Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2029년 9월 1일

연구 등록 날짜

최초 제출

2026년 8월 24일

QC 기준을 충족하는 최초 제출

2026년 8월 27일

처음 게시됨 (실제)

2026년 9월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 1일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • DEV DVB0067
  • 359125 (기타 식별자: IRAS Number)
  • RHM RSP0030 (기타 식별자: Local Reference Number)
  • 25/NE/0225 (기타 식별자: REC ID)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Data may be shared under appropriate governance in accordance with the TidalSense and University Hospital Southampton NHS Foundation Trust agreement

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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