跳至主要内容
临床试验/NCT07833826
NCT07833826招募中不适用

N-WATCH: Nottingham Wheeze Assessment in Tidal Children

University of Nottingham1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2024年7月15日最近更新:
适应症
干预措施

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).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验