Comparing Ultrasonic and Conventional Spirometry in Chronic Respiratory Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spirometer.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD), Spirometry. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Comparative Study of Ultrasonic and Conventional Spirometers in Patients With Chronic Respiratory Diseases
Overview
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 test Spirometer
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.
Primary outcome measures
- Agreement of FEV1 between Ultrasonic and Conventional Spirometers [Time frame: one day]
Secondary outcome measures (1)
- Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility) [Time frame: one day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Taiwan · 1 center
- Cardinal Tien Hospital — New Taipei City
Identifiers
NCT: NCT07447232 · FJUH114492