N-WATCH: Nottingham Wheeze Assessment in Tidal Children

NCT07833826 | Recruiting

• 2 other identifiers: 24023342058
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 1. Percentage (%) of patients approached who enrol in the study

  Feasibility criteria

  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.

Secondary Outcomes (2)

• 1. Proportion (%) of participants who successfully complete a set of capnograms (before and after bronchodilator).

  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

  16 weeks from consent (i.e. less than 16 weeks and 1 day).

Other Outcomes (1)

• Exploratory endpoints

  16 weeks

Study Arms (4)

Acute wheeze - feasibility

Children aged 5 - to less than 16 with acute wheeze admitted to hospital.

Diagnostic Test: N-Tidal

Lung function cohort - feasibility

Children aged 5 to less than 16 with a planned pulmonary function test measurement

Diagnostic Test: N-Tidal

Acute wheeze - main study

Children aged 5 years and less than 16 years admitted with acute wheeze or asthma

Lung function cohort - main study

Children aged 5 years and above attending for routine outpatient lung function testing

Interventions

N-Tidal DIAGNOSTIC_TEST

Capnometry

Acute wheeze - feasibility; Lung function cohort - feasibility

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with asthma wheeze either acutely unwell or attending for lung function testing.

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (2)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

Central Study Contacts

Andrew P Prayle, BMBS

CONTACT

+44 (0) 115 9249924; andrew.prayle@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: September 22, 2026
• Study Start: July 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)