Impedance Pneumography in Assessment of Asthma Control in Preschool Children (IPAAC)
|ClinicalTrials.gov Identifier: NCT03377192|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2017
Last Update Posted : February 13, 2020
|Condition or disease|
|Wheezing Asthma in Children|
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.
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||Impedance Pneumography in Assessment of Asthma Control in Preschool Children|
|Actual Study Start Date :||November 28, 2017|
|Actual Primary Completion Date :||November 14, 2019|
|Estimated Study Completion Date :||June 2020|
- Childhood asthma control test (C-ACT) [ Time Frame: 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.
- Time-to-response (TTR) [ Time Frame: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months ]Duration from visit 1 to good asthma control (C-ACT>19)
- Time-to-loss-of-control (TTLOC) [ Time Frame: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months ]Duration from the visit 2 and 3 until loss of asthma control (C-ACT<16) or asthma exacerbation
- Lung function [ Time Frame: Every visit up to maximum 6 months ]Respiratory resistance and exercise induced increase in resistance, measured by the oscillometric method
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377192
|HUS Skin and Allergy Hospital|
|Helsinki, Finland, 00029|
|Mehiläinen Paediatric Allergy Clinic|
|Helsinki, Finland, 00260|
|Principal Investigator:||Pekka Malmberg, MD, PhD||HUS Skin and Allergy Hospital|