Cardinal Tien Hospital
New Taipei City, 23148, Taiwan
Location status: Recruiting
NCT Number: NCT07447232
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
New Taipei City, 23148, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Fu Jen Catholic University
Other
A Comparative Study of Ultrasonic and Conventional Spirometers in Patients With Chronic Respiratory Diseases
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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