跳至主要内容
临床试验/NCT05632588
NCT05632588已完成不适用

Near Fatal Asthma in Children and Young People

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Number of cases of Near Fatal Asthma reported to British Paediatric Surveillance Unit

研究概览

简要总结

This study will report the frequency, risks factors, clinical care and estimate the future asthma risk of children and young people (aged 5-15 years) experiencing a Delphi defined near fatal asthma (NFA) attacks in the United Kingdom (UK) and Republic of Ireland (ROI). A greater understanding of the frequency and risk factors associated with NFA could help support children and young people (CYP), parents and clinicians to identify and modify risk, both independently and through a resulting clinical care pathway and also develop future research to improve effectiveness of interventions. The study will explore both commonly identified clinical factors, but also for the first time describe in detail the variance in medical management (acute and intensive care) that could lead to future clinical trials and guideline development to standardise care. The study will also describe, through data-linkage, socio-demographic factors associated with NFA, to include pollution, pollen, weather, viral prevalence that could lead to better care for higher risk CYP.

To encourage more consistent, less fragmented care following a near fatal asthma attack, the study will consider how care is provided subsequent to an NFA attack using British Paediatric Surveillance Unit (BPSU) surveillance at 12 and 24 month follow up.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • A child/young person is considered to have experienced an episode of near fatal asthma if they meeting any one of the following:
  • Any child aged 5-15 years surviving* an acute episode of asthma, who when presenting self-ventilating with severe dyspnoea (e.g. inability to speak) and all the following features:
  • Pulse oxygen saturation below 92% despite maximal oxygen therapy (i.e. 10-15l/min oxygen flow via non-rebreather mask) during acute presentation
  • pH <= 7.2 and/or pCO2 >=60mmHg or 8kPa
  • Escalation to use of intravenous bronchodilator infusion
  • Any child aged 5-15 years surviving* an acute episode of asthma, who had a respiratory arrest and/or required cardiopulmonary resuscitation as part of their presentation.
  • Any child age 5-15 years surviving* an acute episode of asthma for which he/she was invasively ventilated.
  • surviving to hospital discharge

排除标准

  • CYP not meeting the case definition will be excluded. An expert panel (consisting of three clinicians) will adjudicate borderline cases.

结局指标

主要结局

Number of cases of Near Fatal Asthma reported to British Paediatric Surveillance Unit

时间窗: 18 months

Descriptive data

次要结局

  • Detailed analysis of the clinical, social and environmental characteristics of those who experience NFA.(18 months)
  • Reporting of the 12 and 24 months following an episode of NFA, estimating the future risk of a health-related asthma event and the healthcare that is provided to those experiencing NFA.(42 months)
  • Detailed analysis of the care provided to CYP who experience NFA at the time of the event, during emergency, in patient and critical care.(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验