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A Longitudinal, Observational Study to Explore the Tidal Breathing Carbon Dioxide (TBCO2) Waveform, Measured Using the N-Tidal C Device, in Asthma
The study involves a new device, called 'N-Tidal C', which uses a method that has the potential to predict when asthma attacks are about to happen. The device works by accurately measuring an individual's exhaled CO2 waveform. A person has to breathe in and out through the mouthpiece at their normal relaxed rate of breathing. It does not need any extra effort and therefore has considerable benefits over current breathing tests which require significant patient effort.
People with more severe asthma suffer from frequent asthma attacks that require regular hospital admissions. These attacks are difficult to predict and can devastate the lives of patients. A new tool is needed that can help to predict when an asthma attack is going to happen. This would help people recognise an attack earlier and allow treatment to be started sooner. This study will evaluate a new breathing monitor, to see whether it can detect asthma attacks. The study tests a new device, called 'N-Tidal C', which uses a method that has the potential to predict when attacks are about to happen. The investigators have found that people with asthma breathe out a gas, called carbon dioxide (CO2), in a different way to healthy people. The pattern of breathing out CO2 (the waveform) changes further when patients are having an attack of their disease. If patients could monitor their CO2, they may recognise when their asthma is getting worse, and take earlier action to avoid attacks getting out of hand and going to hospital.
Age
7 - No limit years
Sex
ALL
Healthy Volunteers
No
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom
Start Date
February 11, 2020
Primary Completion Date
January 20, 2022
Completion Date
January 31, 2022
Last Updated
June 21, 2022
124
ACTUAL participants
Lead Sponsor
TidalSense
Collaborators
NCT07219173
NCT02327897
NCT07486401
Data Source & Attribution
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