DIAGNOSE
Research type
Research Study
Full title
A two-phased multi-centre diagnostic study to evaluate the Tidal Breathing Carbon Dioxide (TBCO2) waveform, measured using the N-Tidal A device, in the diagnosis of asthma
IRAS ID
270244
Contact name
Hitasha Rupani
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
In a small study with a few participants, we found that people with asthma breathe out a gas, called carbon dioxide (CO2), in a different way to people without asthma. The pattern of breathing out CO2 changes further when people with asthma are having an attack. We can see these patterns in a picture called a ‘waveform’. Looking for differences in these waveform patterns could help us to know when a person with breathing difficulties or wheeziness actually has asthma or if their breathing problems are due to a different condition.
To investigate this we will perform the following two-phased study:
In the first phase we will recruit 243 people, including 106 with asthma, 67 with other respiratory diseases and 70 with no known lung disease.
In the second phase we will recruit 143 people with suspected asthma.
Both phases will follow the same schedule of procedures, but crucially between the phases, there will be a period of machine learning so the device can learn to recognize the differences in the waveform in asthma. In both phases, participants will perform all the procedures normally used to diagnose asthma and additionally will perform the N-Tidal Measurement, at a clinic appointment and for 2 weeks of daily recording. By the end of the study we hope to have created a 'breath-print' for asthma, which can then go on to be used more widely in asthma diagnosis.REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0644
Date of REC Opinion
20 Dec 2019
REC opinion
Favourable Opinion