Comparing Ultrasonic and Conventional Spirometry in Chronic Respiratory Disease

NCT07447232 | Recruiting

• 1 other identifier: FJUH114492
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Spirometry

Keywords

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

Outcome Measures

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.

  one day

Secondary Outcomes (1)

• Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility)

  one day

Study Arms (2)

Conventional Spirometer

EXPERIMENTAL

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

Ultrasonic Spirometer

EXPERIMENTAL

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

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.

Conventional Spirometer; Ultrasonic Spirometer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fu Jen Catholic University: lead

Study Sites (1)

Cardinal Tien Hospital

New Taipei City, 23148, Taiwan

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ke-Yun Chao, PhD

  Fu Jen Catholic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Yun Chao, PhD

CONTACT

+886905301879; 148540@mail.fju.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: March 3, 2026
• Study Start: June 29, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 31, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)