N-WATCH: Nottingham Wheeze Assessment in Tidal Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- 1. Percentage (%) of patients approached who enrol in the study
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
Lung function cohort - feasibility
Children aged 5 to less than 16 with a planned pulmonary function test measurement
干预措施: N-Tidal (Diagnostic Test)
Acute wheeze - feasibility
Children aged 5 - to less than 16 with acute wheeze admitted to hospital.
干预措施: N-Tidal (Diagnostic Test)
结局指标
主要结局
1. Percentage (%) of patients approached who enrol in the study
时间窗: 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.
Feasibility criteria
次要结局
- 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).)
