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临床试验/NCT07798596
NCT07798596尚未招募不适用

BREATHE: Benchmarking Respiratory Evaluation of Advanced Technologies for Healthcare Excellence

University Hospital Southampton NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
300
试验地点
2
主要终点
Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 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)

排除标准

  • 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

研究组 & 干预措施

GP direct access spirometry within community diagnostic centres

Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres

干预措施: Capnography (Diagnostic Test)

GP direct access spirometry within community diagnostic centres

Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres

干预措施: FENO (Diagnostic Test)

GP direct access spirometry within community diagnostic centres

Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres

干预措施: Oscillometry (Diagnostic Test)

Full lung function testing within secondary care hospitals

Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals

干预措施: Oscillometry (Diagnostic Test)

Full lung function testing within secondary care hospitals

Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals

干预措施: FENO (Diagnostic Test)

GP direct access spirometry within community diagnostic centres

Adults with suspected COPD/airway disease referred for spirometry testing at local community diagnostic centres

干预措施: Spirometry (Diagnostic Test)

Full lung function testing within secondary care hospitals

Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals

干预措施: Capnography (Diagnostic Test)

Full lung function testing within secondary care hospitals

Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals

干预措施: Gas Transfer (Diagnostic Test)

Full lung function testing within secondary care hospitals

Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals

干预措施: Static Lung Volumes (Diagnostic Test)

Full lung function testing within secondary care hospitals

Adults with suspected COPD/airway disease referred for full lung function testing at secondary care hospitals

干预措施: Spirometry (Diagnostic Test)

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

干预措施: Capnography (Diagnostic Test)

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

干预措施: Oscillometry (Diagnostic Test)

Community outreach

Adults with suspected COPD/airway disease attending local community groups and events

干预措施: Capnography (Diagnostic Test)

Community outreach

Adults with suspected COPD/airway disease attending local community groups and events

干预措施: Oscillometry (Diagnostic Test)

结局指标

主要结局

Diagnostic accuracy of capnography used in combination with machine learning-derived algorithms

时间窗: Baseline

Sensitivity, Specificity, PPV, NPV compared to clinician diagnosis of COPD

次要结局

  • Diagnostic accuracy of oscillometry(Baseline)
  • Feasibility outcomes(Baseline)
  • Usability and acceptability outcomes(Baseline)
  • Effectiveness of advanced technologies in detecting early, alternative, or precursor respiratory conditions(Baseline)
  • Feasibility outcomes in Lung Cancer Screening pathway(Baseline)
  • Time per test(Baseline)
  • Comparative 'failure rate'(Baseline)
  • Usability and acceptability(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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