Respiratory Oscillometry Norms for Polish Children and Adolescent.

NCT07207720 | Completed DMC

• 1 other identifier: OSCILLONiCA-PL-Kids 01/2023
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to establish normative values for respiratory oscillometry in the Polish pediatric population. It is designed as a multicentre, population-based, prospective cohort study including children and adolescents aged 3-18 years. The results will provide reference standards for respiratory oscillometry that may support the diagnosis and monitoring of respiratory diseases in clinical practice and research.

Conditions

Healthy; Pulmonary Function Test

Keywords

Reference Values; Oscillometry; Impulse Oscillometry; Respiratory Mechanics; Children; Adolescents; Poland; pulmonary function test

Outcome Measures

Primary Outcomes (1)

• Reference values and z-score distributions for respiratory oscillometry parameters (Rrs, Xrs, Fres, AX) in healthy Polish children and adolescents

  Quantitative reference data for respiratory oscillometry parameters - respiratory resistance (Rrs) and reactance (Xrs) at 5, 10, and 20 Hz, resonance frequency (Fres), and area of reactance (AX) - measured using impulse oscillometry (IOS) in healthy children and adolescents aged 3-18 years. Results will be summarized as mean (Units of Measure: Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹); standard deviation (SD), percentiles, and z-score distributions stratified by age, height, and sex.

  Single assessment at baseline (during one study visit).

Secondary Outcomes (6)

• Prediction equations and z-score reference models for oscillometric parameters (Rrs, Xrs, Fres, AX)

  At baseline (single study visit).

• Variability of respiratory oscillometry parameters (Rrs, Xrs, Fres, AX) across pediatric age groups

  At baseline (single study visit).

• Z-score distributions for oscillometry parameters across Polish and international pediatric cohorts

  Up to 24 months after completion of data collection (estimated by December 2026).

• Nomograms and percentile charts for clinical use

  Through study completion, approximately 36 months after study start (January 2023 - December 2025).

• De-identified reference dataset of pediatric oscillometry measurements

  Through study completion, approximately 36 months after study start (January 2023 - December 2025).

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Polish children and adolescents aged 3 to 18 years. Participants are recruited from schools, kindergartens, and pediatric outpatient clinics across 12 centers in Poland. Only individuals without chronic respiratory diseases or recent respiratory infections are eligible.

You may qualify if:

• \. Written informed consent from a parent/legal guardian (for participants \<16 years) or from the participant if ≥16 years.

You may not qualify if:

• \. Acute respiratory infection within 4 weeks before testing. 3. Severe chronic comorbidities (e.g., congenital heart disease, neuromuscular disorders).
• \. Chest deformation 5. Inability to perform oscillometry according to ERS standards.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk

Gdansk, Gdańsk, 80-211, Poland

Location

Related Publications (4)

• Kaminsky DA, Simpson SJ, Berger KI, Calverley P, de Melo PL, Dandurand R, Dellaca RL, Farah CS, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, King GG, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oostveen E, Oppenheimer BW, Robinson PD, van den Berge M, Thamrin C. Clinical significance and applications of oscillometry. Eur Respir Rev. 2022 Feb 9;31(163):210208. doi: 10.1183/16000617.0208-2021. Print 2022 Mar 31.

  PMID: 35140105 BACKGROUND

• King GG, Bates J, Berger KI, Calverley P, de Melo PL, Dellaca RL, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, Kaminsky DA, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oppenheimer BW, Simpson SJ, Thamrin C, van den Berge M, Oostveen E. Technical standards for respiratory oscillometry. Eur Respir J. 2020 Feb 27;55(2):1900753. doi: 10.1183/13993003.00753-2019. Print 2020 Feb.

  PMID: 31772002 BACKGROUND

• Desai U, Joshi JM. Impulse oscillometry. Adv Respir Med. 2019;87(4):235-238. doi: 10.5603/ARM.a2019.0039.

  PMID: 31476011 BACKGROUND

• de Oliveira Jorge PP, de Lima JHP, Chong E Silva DC, Medeiros D, Sole D, Wandalsen GF. Impulse oscillometry in the assessment of children's lung function. Allergol Immunopathol (Madr). 2019 May-Jun;47(3):295-302. doi: 10.1016/j.aller.2018.03.003. Epub 2018 Jul 5.

  PMID: 29983239 BACKGROUND

Related Links

• This external link directs to the official website of the Polish Society of Pediatric Pulmonology (PTPD), which provides information about the OSCILLONiCA-PL Kids study. The page contains a public description of the project "Respiratory Oscillometry - Es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 6, 2025
• Study Start: January 10, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

PL (1)