Cardiorespiratory Diagnostic Study (CARES)
Research type
Research Study
Full title
A longitudinal observational study to investigate the patterns of change in the Tidal Breathing Carbon Dioxide (TBCO2) waveform, measured using the N-Tidal C Handset, in patients with Chronic Obstructive Pulmonary Disease (COPD) compared to patients with other common cardiorespiratory conditions.
IRAS ID
297863
Contact name
Ameera Patel
Contact email
Sponsor organisation
Cambridge Respiratory Innovations Limited
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
This study is investigating whether the changes in the CO2 waveform shape that occur during normal relaxed breathing in COPD are distinct from those that occur in other common cardiorespiratory conditions, and whether the N-Tidal C device (which measures CO2 during normal breathing) can be used to assist in the diagnosis of COPD.
When people are unwell, the pattern of respired CO2 changes compared to healthy people. The NTC uses CO2 measurements as a way of tracking small changes in lung physiology that can alert to a wide variety of underlying lung problems, such as small airway narrowing.
Eligible participants will either be healthy (no history of heart or lung conditions) or will have one of the following conditions: COPD, asthma, heart failure, bronchiectasis, anaemia, lung cancer, pulmonary fibrosis, long COVID, an upper airway obstruction condition, pulmonary embolism, pulmonary hypertension, or extrinsic allergic alveolitis.
Patients will be recruited from among the primary care patient population served by the Modality (GP) partnership. All participants will receive a NTC kit for use in their home environment and will be asked to use the device twice a day for two weeks. Participants will be provided with remote (video-based) training on the NTC by the clinical study team. Devices will be delivered and collected by courier service which will be coordinated by the research team.
During that two-week period, participants will be asked to fill in a daily diary to report on changes to symptoms and medications. In addition, participants will have the option of participating in a short user experience questionnaire.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
21/YH/0094
Date of REC Opinion
27 Apr 2021
REC opinion
Favourable Opinion