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Forced oscillation technique: a novel method to monitor pulmonary fibrosis

Forced oscillation technique: a novel method to monitor pulmonary fibrosis - FLAIR2 study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57392
Enrollment
125
Registered
2025-04-08
Start date
2025-02-03
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

interstitial lung disease pulmonary fibrosis

Interventions

None listed

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients with pulmonary fibrosis aged 18 years and older

Exclusion criteria

Exclusion criteria: pregnancy breast feeding

Design outcomes

Primary

MeasureTime frame
• Spirometrie parameter: o Forced vital capacity (FVC) o Forced expiratory volume in 1s (FEV1) • Difusing capacity of carbondioxide (DLCO) • Multiple FOT-parameters: o Respiratory reactance (X5) --> retraction capacity + degree of peripheral obstruction o Respiratory resistance (R5) --> total respiratory resistance (large airways + small airways + extrathoracic airways like the oropharynx and larynx) o Respiratory resistance (R5) 20-15 Hz (Rrs20-5) --> small airways index • RAND-36 • 5-point Likert-scale

Secondary

MeasureTime frame
Questionnaires Patient Evaluation Form: - VAS Cough: A visual analog scale (VAS) to assess the intensity of coughing experienced by the patient during the procedure. - VAS Shortness of Breath: A VAS to measure the severity of breathlessness during the procedure. - VAS Comfort: A VAS to evaluate the overall comfort level of the patient during the test. - General Procedure Feedback: Open-ended section for patients to provide feedback on the procedure, including any suggestions or issues encountered. - Quality of life questionnaires (RAND-36 & L-PF) Staff Evaluation Form: Procedure Duration: Record the total time taken to complete the procedure. Was it possible to perform the lung function and/or FOT measurement? No: Provide a reason for the failure to complete the measurement: - Coughing - Shortness of breath - Fatigue/Low energy Yes: - Assess the Quality of the Measurement: Rate on a scale: poor - moderate - adequate - good. - Number of Attempts: Document how many attempts were required to obtain a usable measurement. - Variation Between Measurements: Record any inconsistencies or variability across repeated measurements. - Medical Conclusion Based on the Results: Provide a clinical interpretation of the results, considering the quality and reliability of the data obtained.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)