Impedance Pneumography in Assessment of Asthma Control in Preschool Children

• Conditions: Wheezing; Asthma in Children

• Registration Number: NCT03377192
• Lead Sponsor: HUS Skin and Allergy Hospital

Brief Summary

This study evaluates the value of impedance pneumography, used as overnight home recordings during a longitudinal design, in assessing asthma control in preschool children

Detailed Description

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 Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-19
• Primary Completion: 2019-11-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-13
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Childhood asthma control test (C-ACT)	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.

Secondary Outcome Measures

Name	Time	Method
Time-to-loss-of-control (TTLOC)	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
Time-to-response (TTR)	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)
Lung function	Every visit up to maximum 6 months	Respiratory resistance and exercise induced increase in resistance, measured by the oscillometric method

Trial Locations

Locations (2)

HUS Skin and Allergy Hospital; 🇫🇮 Helsinki, Finland

Mehiläinen Paediatric Allergy Clinic; 🇫🇮 Helsinki, Finland