Respiratory Oscillometry Norms for Polish Children and Adolescent. (OSCILLONiCA-PL)

Respiratory Oscillometry - Establishing Reference Values in Polish Children and Adolescents Aged 3-18 Years (OSCILLONiCA-PL-Kids)

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Pulmonary Function Test

Detailed Description

OSCILLONiCA-PL-Kids is a multicentre, observational, cross-sectional study designed to establish normative reference values for respiratory oscillometry (IOS) in healthy Polish children and adolescents aged 3-18 years. The study is coordinated by the Polish Society of Pediatric Pulmonology and conducted in 12 pediatric centers across Poland between 2023 and 2025.

Standardized Jaeger oscillometry systems (ERS-validated) are used across all sites, following harmonized operating procedures. All investigators and technicians undergo centralized training and certification, with periodic audits and refresher sessions to ensure procedural consistency and data quality. Measurements are performed during tidal breathing with cheek support and a nose clip, recording at least three technically acceptable trials per participant. Parameters include resistance (Rrs) and reactance (Xrs) at 5, 10, and 20 Hz, resonance frequency (Fres), and area of reactance (AX).

Anthropometric data (height, weight, age, sex) are collected simultaneously to allow modeling of predicted values. Data integrity is verified using automated quality-control algorithms. Reference equations for oscillometric parameters will be derived using generalized additive models for location, scale, and shape (GAMLSS, LMS method). Model performance will be evaluated using the Schwarz Bayesian Criterion, with sensitivity analyses assessing robustness to borderline cases and environmental exposures.

Raw measurement data, as well as derived parameters (means, standard deviations, percentiles, and z-scores), will be used to generate normative reference values and percentile charts stratified by age, height, and sex.

Quality assurance: Data collection and management follow standardized operating procedures (SOPs) approved by the coordinating center. Each site conducts internal data validation prior to upload, and periodic cross-site audits are performed to ensure compliance and consistency. Automatic range and logic checks are implemented in the database to flag out-of-range or inconsistent entries.

Missing data plan: Incomplete or invalid recordings will be excluded from normative modeling. Sensitivity analyses will evaluate the impact of missing data on reference equations. Imputation will not be used for normative dataset derivation.

The study adheres to ERS Technical Standards for Oscillometry (2020) and complies with Good Clinical Practice for observational research. The resulting reference equations and percentile charts will provide validated normative standards for pediatric oscillometry in Poland and support future international harmonization efforts.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• Poland
  • Gdańsk
    • Gdansk, Gdańsk, Poland, 80-211
      • Medical University of Gdansk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:1. Age between 3 and 18 years. 2. Caucasian race (Born and residing in Poland). 3. Absence of chronic respiratory disease or acute respiratory symptoms at the time of testing.

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

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Exclusion Criteria:1. History of chronic lung disease (e.g., asthma, cystic fibrosis, bronchopulmonary dysplasia, interstitial lung disease).

2. Acute respiratory infection within 4 weeks before testing. 3. Severe chronic comorbidities (e.g., congenital heart disease, neuromuscular disorders).

4. Chest deformation 5. Inability to perform oscillometry according to ERS standards.

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction equations and z-score reference models for oscillometric parameters (Rrs, Xrs, Fres, AX)	Regression models describing the relationship between oscillometric parameters (Rrs, Xrs, Fres, AX) and anthropometric predictors (age, height, weight, sex). Models will be developed using the Generalized Additive Models for Location, Scale, and Shape (GAMLSS; LMS method). Predicted means, SDs, and z-score equations will be reported, together with model coefficients, standard errors, and model fit indices (Schwarz Bayesian Criterion). Units of Measure: Model coefficients (unitless); Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹; z-scores: dimensionless	At baseline (single study visit).
Variability of respiratory oscillometry parameters (Rrs, Xrs, Fres, AX) across pediatric age groups	Mean and standard deviation of oscillometry parameters - respiratory resistance (Rrs, kPa·s·L-¹), reactance (Xrs, kPa·s·L-¹), resonance frequency (Fres, Hz), and area of reactance (AX, kPa·L-¹) - compared across three predefined pediatric age groups: preschool (3-5 years), school-aged (6-12 years), and adolescents (13-18 years). All parameters will also be expressed as z-scores (dimensionless) for standardized inter-group comparison.Units of Measure: Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹; z-scores: dimensionless.	At baseline (single study visit).
Z-score distributions for oscillometry parameters across Polish and international pediatric cohorts	Z-score distributions for respiratory resistance (Rrs), reactance (Xrs), resonance frequency (Fres), and area of reactance (AX) derived from the OSCILLONiCA-KIDS dataset and published international reference datasets (Austria). Differences between cohorts will be summarized as mean z-score differences and limits of agreement.	Up to 24 months after completion of data collection (estimated by December 2026).
Nomograms and percentile charts for clinical use	Nomograms and percentile charts illustrating predicted oscillometry parameters (Rrs, Xrs, Fres, AX) across age, height, and sex categories will be created to support clinical interpretation. Each chart will include mean, standard deviation (SD), percentiles (5th, 25th, 50th, 75th, 95th), and corresponding z-score ranges.Units of Measure: Rrs, Xrs: kPa·s·L-¹; Fres: Hz; AX: kPa·L-¹; z-scores: dimensionless	Through study completion, approximately 36 months after study start (January 2023 - December 2025).
De-identified reference dataset of pediatric oscillometry measurements	A de-identified dataset containing oscillometry and anthropometric data (age, height, weight, sex, Rrs, Xrs, Fres, AX) will be compiled for research use and potential integration into international reference initiatives (e.g., Global Lung Function Initiative). Dataset records will be reported as counts of included participants and data completeness metrics. Units of Measure: Number of data records (n); data completeness (%)	Through study completion, approximately 36 months after study start (January 2023 - December 2025).
Quality and performance indicators of school-based oscillometry testing	Proportion of technically acceptable recordings, coefficient of variation (CoV) between repeated trials, and proportion of children successfully completing valid measurements during school-based testing sessions. Units of Measure: Percentage of valid recordings (%); coefficient of variation (%)	Throughout data collection, approximately January 2023 - June 2025.

Collaborators and Investigators

• Sponsor: Medical University of Gdansk

Publications and helpful links

General Publications

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

Helpful 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 record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: September 22, 2025
• First Submitted That Met QC Criteria: October 2, 2025
• First Posted (Estimated): October 6, 2025

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Children; pulmonary function test; Respiratory Mechanics; Reference Values; Oscillometry; Impulse Oscillometry; Poland
• Other Study ID Numbers: OSCILLONiCA-PL-Kids 01/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The study team will consider sharing de-identified individual participant data after publication of the primary results, depending on institutional policies and ethical approval.

Drug and device information, study documents

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