Chronic Obstructive Pulmonary Disease (COPD), Spirometry
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Spirometry, Ultrasonic Flow Sensor, Pulmonary Function Test
Brief summary
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.
Detailed description
This study aims to compare a new ultrasonic handheld spirometer with the standard hospital spirometer used in lung function testing. We want to find out whether the ultrasonic device can measure breathing strength and lung capacity as accurately and reliably as the traditional machine. Adults with chronic respiratory diseases-including COPD, asthma, bronchiectasis, and interstitial lung disease-will participate. Each participant will perform lung function tests using both devices in a randomized order. The results from the two methods will then be compared to see how closely they match. The goal of this study is to determine whether the ultrasonic spirometer can be used as a convenient alternative tool for lung function monitoring in clinics, community settings, or at home.
Interventions
DIAGNOSTIC_TESTSpirometer
The 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.
Sponsors
Fu Jen Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of FEV1 between Ultrasonic and Conventional Spirometers | one day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility) | one day | Assessment of within-device repeatability of the ultrasonic spirometer across three forced expiratory maneuvers, evaluated by intraclass correlation coefficients (ICC) and coefficient of variation. |
Countries
Taiwan
Contacts
CONTACTKe-Yun Chao, PhD
PRINCIPAL_INVESTIGATORKe-Yun Chao, PhD
Fu Jen Catholic University
Outcome results
None listed