An observational study in Asthma in Children, sponsored by University of Nottingham. Recruiting at 2 sites in United Kingdom. Open to participants aged 5 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University of Nottingham · Observational
Children with long-term lung diseases like asthma need better techniques for diagnosis and monitoring of their disease. With better monitoring, it is anticipated that children and their carers will be able to manage their disease better, and be able to spot a deterioration in their condition sooner, leading to earlier intervention, for example to prevent an asthma attack.
However, current devices which could be used at home are either too costly, require machines that are impractically large, or require specific breathing maneuvers which are unpopular with patients, or which are difficult for younger children to perform. There is a need for better devices.
The N-Tidal C is a CE Marked medical device which measures exhaled carbon dioxide levels accurately. Early work in its use in adult diseases such as Chronic Obstructive Pulmonary Disease indicates that the device can detect altered lung function associated with disease.
This device has several attractive properties for children - it is small, easy to use, and does not require specific breathing maneuvers - just normal breathing.
Based on data from a small feasibility study, the study investigators believe that this device will be useful in children. Young children can use it with minimal instruction. Parents and children have reported that it is easy to use.
The investigators do not yet have sufficient feasibility information required to plan a larger study, such as deciding how many children the future study will need to recruit, or knowing how well the measurements made with the device agree with standard lung function tests.
In this work, the investigators are conducting a feasibility study to determine the number of children needed for a larger trial and to explore how well the N-Tidal C device measurements compare with standard lung function tests. Data from this study will be used to plan future larger studies of the device in children with respiratory diseases.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 340 is above the median of 158 across 1,250 observational studies indexed under Asthma.
Browse Asthma studies →University of Nottingham is the lead sponsor of 465 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with asthma wheeze either acutely unwell or attending for lung function testing.
Workstream 1 inclusion criteria i) Aged 5 years or older, and less than 15 years plus 32 weeks of age ii) Participant has presented to hospital with acute wheeze, bronchospasm or asthma iii) Participant is not critically ill and is able to breathe into a mouthpiece for 90seconds.
Workstream 2 inclusion criteria i) Participant 5 years or older, and less than 16 years of age. ii) Participant is due to have routine lung function testing.
Exclusion criteria i) Life threatening respiratory difficulties (defined as cyanosis, oxygen saturations less than 92% despite oxygen supplementation, silent chest on auscultation, poor respiratory effort, fatigue or exhaustion, agitation or reduced level of consciousness) ii) Participation in another research project whose protocol prevents participation in this project.
Children aged 5 - to less than 16 with acute wheeze admitted to hospital.
Diagnostic Test: N-Tidal
Children aged 5 to less than 16 with a planned pulmonary function test measurement
Diagnostic Test: N-Tidal
Children aged 5 years and less than 16 years admitted with acute wheeze or asthma
Children aged 5 years and above attending for routine outpatient lung function testing
Capnometry
1. Percentage (%) of patients approached who enrol in the study
Feasibility criteria
Time frame: At recruitment. Participants will be given at least 24 hours to consider whether they would like to enrol in the study. If they have not enrolled in the study within 7 completed days, they will have been approached but not enrolled.
1. Proportion (%) of participants who successfully complete a set of capnograms (before and after bronchodilator).
To meet this criteria enrolled participants have a capnogram meeting study SOP defined quality control metrics before and after bronchodilator.
Time frame: From enrolment to end of hospital inpatient stay. This will be through study completion, average of 7 days or less.
2. Proportion (%) of participants who return for a follow up visit
Enrolled participants will be invited back to have a follow up capnogram in a window from 8 - 16 weeks after consent. If they attend the follow up visit they will meet this study endpoint criteria.
Time frame: 16 weeks from consent (i.e. less than 16 weeks and 1 day).
Exploratory endpoints
Data quality (% of participants able to complete a capnogram which meets study specific quality control within the study SOP) Workstream 1: A exploratory machine learning model which takes metric from the capnogram (e.g. respiratory rate (breaths per minute), alpha angle (in degrees), capnogram phase 3 angle in degrees. The capnograms will be grouped into two groups - before treatment(with bronchodilator) and paired pre-treatment and the ability of the machine learning model to cluster into these two groups will be compared. Workstream 2: A machine learning model to compare the capnogram for patients grouped into their underlying diagnosis of "asthma", "suspected asthma", "healthy" or "other disease". The same input to the machine learning model are included and the ability to discriminate between groups based on capnogram will be evaluated with standard metrics of sensitivity and specificity and ROC curves.
Time frame: 16 weeks
Plan to share: No
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