Impedance Pneumography in Assessment of Asthma Control in Preschool Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Childhood asthma control test (C-ACT)
研究概览
简要总结
This study evaluates the value of impedance pneumography, used as overnight home recordings during a longitudinal design, in assessing asthma control in preschool children
详细描述
Lung function assessment of preschool children is hindered by their limited co-operation in conventional tests such as peak expiratory flow (PEF) or spirometry. However, indices derived from spontaneous tidal respiratory air flow and the shape of tidal expiratory flow-volume and flow-time curves relate to lung function and are easier to record even in young children. As a more advanced approach, the time dynamics and complexity properties of the tidal breathing flow volume (TBFV) signal have been analysed and found to relate to various respiratory conditions.
Impedance pneumography (IP) is a method for measuring changes in the thoracic electrical impedance through skin electrodes, which varies as a function of lung aeration i.e. breathing. Recent technical advancements have enabled IP to be used for accurate non-invasive tidal flow signal measurement. Moreover, in overnight recordings at home, IP was found feasible for quantifying nocturnal TBFV variability in young children with lower respiratory symptoms, showing that preschool children with high risk of asthma present with increased variation of tidal flow profile shape, and momentarily lowered chaoticity, compared to children with lower risk of asthma. So far, there are no studies that have addressed the utility of IP to assess asthma control in young children with asthma.
The purpose of this study is to investigate the utility of a commercially available IP device (VENTICA, Icare Finland, Finland) and IP-derived clinical indices in assessing the clinical control of asthmatic children receiving normal therapy in a longitudinal setting. The primary hypothesis is that TBFV variability quantified by IP is associated with disease control during management of young children with asthma. The secondary hypothesis is that TBFV variability quantified by IP predicts changes in disease control during management of young children with asthma.
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
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-7 years, both sexes
- •Attending pediatric ward in the study centre due to asthmatic symptoms (wheeze, cough and/or dyspnea)
- •History and clinical signs allowing diagnosis of doctor diagnosed asthma and the need to start regular anti-asthmatic medication
- •Signed informed consent
排除标准
- •Use of inhaled corticosteroid medication 30 days prior to study entry
- •Other cardiorespiratory or neurological chronic diseases or states that may affect breathing
- •Acute respiratory infection 2 weeks prior to study entry
- •Chronic respiratory disorder of prematurity
- •Implanted or external active medical devices
结局指标
主要结局
Childhood asthma control test (C-ACT)
时间窗: Weekly up to maximum 6 months or until loss of asthma control/exacerbation
Questionnaire that measures current asthma control, including 7 questions and a minimum score of 0 and maximum score of 27; score 19 or less indicates that asthma is not controlled.
次要结局
- Time-to-loss-of-control (TTLOC)(Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months)
- Time-to-response (TTR)(Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months)
- Lung function(Every visit up to maximum 6 months)
研究者
Pekka Malmberg, MD, PhD
Head of clinical physiology
HUS Skin and Allergy Hospital