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NCT Number: NCT07447232

Comparing Ultrasonic and Conventional Spirometry in Chronic Respiratory Disease

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardinal Tien Hospital

New Taipei City, 23148, Taiwan

Location status: Recruiting

Location contact

Ke-Yun Chao, PhD

CONTACT

[email protected]

+886-905-301-879

Ke-Yun Chao, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

spirometer

Diagnostic Test

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 outcomes

  1. Agreement of FEV1 between Ultrasonic and Conventional Spirometers

    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.

Secondary outcomes

  1. Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ke-Yun Chao, PhD

CONTACT

[email protected]

+886905301879

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University

Other

Registry information

Official study title

A Comparative Study of Ultrasonic and Conventional Spirometers in Patients With Chronic Respiratory Diseases

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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