A Comparative Study of Ultrasonic and Conventional Spirometers in Patients With Chronic Respiratory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Agreement of FEV1 between Ultrasonic and Conventional Spirometers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Spirometer (Diagnostic Test)
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.
干预措施: Spirometer (Diagnostic Test)
结局指标
主要结局
Agreement of FEV1 between Ultrasonic and Conventional Spirometers
时间窗: 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.
次要结局
- Test-Retest Reliability of Ultrasonic Spirometer (Reproducibility)(one day)
研究者
Ke-Yun, Chao
Assistant Professor
Fu Jen Catholic University