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RecruitingNCT07447232Updated Jul 2, 2026

Comparing Ultrasonic and Conventional Spirometry in Chronic Respiratory Disease

An interventional study of Spirometer in Chronic Obstructive Pulmonary Disease (COPD) and Spirometry, sponsored by Fu Jen Catholic University. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Fu Jen Catholic University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Spirometry

Keywords

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Spirometry
  • Ultrasonic Flow Sensor
  • Pulmonary Function Test
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Fu Jen Catholic University is the lead sponsor of 43 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Conventional Spirometer

    Standard hospital spirometry performed according to ATS/ERS procedures to obtain FEV1, FVC, and PEF. In this study, spirometry is performed using the Conventional Spirometer first, followed by the Ultrasonic Spirometer.

    Diagnostic Test: Spirometer

  • Experimental
    Ultrasonic Spirometer

    Standard hospital spirometry performed according to ATS/ERS procedures to obtain FEV1, FVC, and PEF. In this study, spirometry is performed using the Ultrasonic Spirometer first, followed by the Conventional Spirometer.

    Diagnostic Test: Spirometer

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.

06

What researchers measure

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 day

Secondary 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 day

07

Study locations

1 of 1 sites recruiting
  • Cardinal Tien Hospital
    New Taipei City, 23148, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07447232
Lead sponsor
Fu Jen Catholic University
Responsible party
Ke-Yun, Chao (Assistant Professor, Fu Jen Catholic University) — Principal investigator
First posted
Mar 3, 2026
Start date
Jun 29, 2026
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jul 2, 2026

Study contacts

Ke-Yun Chao, PhD
Contact
148540@mail.fju.edu.tw
+886905301879
Ke-Yun Chao, PhD
principal investigator · Fu Jen Catholic University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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