N-WATCH: Nottingham Wheeze Assessment in Tidal Children

University of Nottingham340 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

340

Conditions

Asthma in Children

Eligibility

Sex: ALLMin age: 5 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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).