Comparing Ultrasonic and Conventional Spirometry in Chronic Respiratory Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFu Jen Catholic University
About this trial
This study compares a handheld ultrasonic spirometer with a standard hospital spirometer in adults with chronic respiratory diseases. Each participant will complete lung function tests using both devices. The study aims to determine whether the ultrasonic device provides accurate and reliable measurements for use in clinical or home settings.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 80 years.
Diagnosed with a chronic respiratory disease (e.g., COPD, asthma, bronchiectasis, or interstitial lung disease).
Willing to follow the instructions for using the ultrasonic spirometer.
Clinically stable and able to understand the study purpose and procedures, and who provide informed consent.
Disqualifiers
Individuals who, after explanation, are still unable to properly perform the ultrasonic spirometry procedure.
Individuals who, after explanation, refuse to participate in the study.
Patients with unstable vital signs.
Pregnant or suspected pregnant women.
Trial design
Design model
Crossover
Treatments tested in this trial
Spirometer
Diagnostic testThe handheld ultrasonic spirometry device uses acoustic flow analysis to measure FEV1, FVC, and PEF and is evaluated for accuracy compared with the conventional spirometer. Participants may perform this test either before or after the conventional spirometry test, depending on the randomized crossover sequence.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Conventional SpirometerExperimental treatment 1 intervention
Group B: Ultrasonic SpirometerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Agreement of FEV1 between Ultrasonic and Conventional Spirometers
Agreement of forced expiratory volume in one second (FEV1) measured by the ultrasonic spirometer compared with the conventional spirometer, assessed using Bland-Altman analysis and correlation coefficients.
Time frame
one daySecondary outcomes
1
Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility)
Assessment of within-device repeatability of the ultrasonic spirometer across three forced expiratory maneuvers, evaluated by intraclass correlation coefficients (ICC) and coefficient of variation.
Time frame
one daySponsors and contacts
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Source ClinicalTrials.gov