Impedance Pneumography in Assessment of Asthma Control in Preschool Children (IPAAC)

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

Study Overview

• Status: Unknown
• Conditions: Asthma in Children; Wheezing

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 Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • HUS Skin and Allergy Hospital
  • Helsinki, Finland, 00260
    • Mehiläinen Paediatric Allergy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Thirty (30) patients who have attended pediatric ward in the study centre(s) due to asthmatic symptoms (wheeze, cough, dyspnea) will be recruited.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood asthma control test (C-ACT)	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.	Weekly up to maximum 6 months or until loss of asthma control/exacerbation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-response (TTR)	Duration from visit 1 to good asthma control (C-ACT>19)	Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Time-to-loss-of-control (TTLOC)	Duration from the visit 2 and 3 until loss of asthma control (C-ACT<16) or asthma exacerbation	Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Lung function	Respiratory resistance and exercise induced increase in resistance, measured by the oscillometric method	Every visit up to maximum 6 months

Collaborators and Investigators

• Sponsor: HUS Skin and Allergy Hospital
• Collaborators: Revenio Research; Mehiläinen
• Investigators: Principal Investigator: Pekka Malmberg, MD, PhD, HUS Skin and Allergy Hospital

Publications and helpful links

General Publications

• Burman J, Malmberg LP, Remes S, Jartti T, Pelkonen AS, Makela MJ. Impulse oscillometry and free-running tests for diagnosing asthma and monitoring lung function in young children. Ann Allergy Asthma Immunol. 2021 Sep;127(3):326-333. doi: 10.1016/j.anai.2021.03.030. Epub 2021 Apr 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 28, 2017
• Primary Completion (ACTUAL): November 14, 2019
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (ACTUAL): December 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 12, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Asthma management; Respiratory function; Impedance pneumography
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Respiratory Sounds
• Other Study ID Numbers: VCS-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No