Gao Yi, Liang Binmiao, Su Xibin, Rao Wentao, Cheng Huitong, Fan Chonghui, Yu Xinxin, Xie Yanqing, Shen Beilan, Du Jing, Li Linwei, Liu Binjian
National Center for Respiratory Medicine, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.
Department of Pulmonary and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan, People's Republic of China.
BMC Pulm Med. 2025 May 10;25(1):228. doi: 10.1186/s12890-025-03690-1.
Access to spirometry remains limited due to the expense and inconvenience of stationary laboratory spirometers, which may compromise the diagnosis and management of chronic respiratory diseases (CRDs), such as chronic obstructive pulmonary disease (COPD) and asthma. Portable spirometers offer potential advantages over laboratory spirometers in terms of affordability, user-friendliness, and portability. The objective of this study is to evaluate the reliability and usability of a portable spirometer (Medcaptain VC-30 Pro) compared to a conventional laboratory spirometer (Jaeger MasterScreen PFT).
In this multi-center, randomized, open-label crossover study, 132 subjects from two hospitals were recruited to perform pulmonary function tests using both the portable spirometer and the laboratory spirometer. Forced expiratory volume in one second (FEV), forced vital capacity (FVC), FEV/FVC ratio, peak expiratory flow (PEF), forced expiratory flow between 25 and 75% of FVC (FEF), vital capacity (VC), maximal voluntary ventilation (MVV), and forced expiratory volume in six seconds (FEV) were compared for correlation and agreement between two spirometers. The concordance of their spirometric abnormality diagnoses and severity classifications was assessed. An additional 30 healthy volunteers were recruited to perform a pulmonary function test by themselves after a session guided by specialists to evaluate the usability of the portable spirometer.
A total of 126 recruited participants achieved acceptable pulmonary function test results. The intraclass correlation coefficients (ICCs) for primary outcomes FEV and FVC were 0.994 and 0.993, respectively (both p < 0.001). ICCs for other outcomes ranged from 0.968 to 0.995 (all p < 0.001). The Bland-Altman analysis showed that FEV and FVC met preset acceptable criteria, with 96.0% of values falling within the 95% limits of agreement (LoA). Cohen's kappa statistics for the diagnosis of spirometric abnormality and classification of severity were 0.872 and 0.878, respectively. In the usability test, 28 out of 30 volunteers obtained a Grade A result.
The portable spirometer exhibited a strong correlation and agreement with a high-quality laboratory spirometer, as well as concordance in spirometric abnormality diagnosis and severity classification. Non-specialist can obtain acceptable results using this portable spirometer.
由于固定式实验室肺功能仪价格昂贵且使用不便，获取肺功能检测的机会仍然有限，这可能会影响慢性呼吸道疾病（CRD）的诊断和管理，如慢性阻塞性肺疾病（COPD）和哮喘。便携式肺功能仪在可承受性、用户友好性和便携性方面比实验室肺功能仪具有潜在优势。本研究的目的是评估一款便携式肺功能仪（Medcaptain VC-30 Pro）与传统实验室肺功能仪（耶格MasterScreen PFT）相比的可靠性和可用性。
在这项多中心、随机、开放标签交叉研究中，招募了来自两家医院的132名受试者，使用便携式肺功能仪和实验室肺功能仪进行肺功能测试。比较了一秒用力呼气容积（FEV）、用力肺活量（FVC）、FEV/FVC比值、呼气峰值流速（PEF）、FVC的25%至75%之间的用力呼气流量（FEF）、肺活量（VC）、最大自主通气量（MVV）和六秒用力呼气容积（FEV），以评估两种肺功能仪之间的相关性和一致性。评估了它们在肺功能异常诊断和严重程度分类方面的一致性。另外招募了30名健康志愿者，在专家指导的一次培训后自行进行肺功能测试，以评估便携式肺功能仪的可用性。
总共126名招募的参与者获得了可接受的肺功能测试结果。主要指标FEV和FVC的组内相关系数（ICC）分别为0.994和0.993（均p<0.001）。其他指标的ICC范围为0.968至0.995（均p<0.001）。Bland-Altman分析表明，FEV和FVC符合预设的可接受标准，96.0%的值落在95%一致性界限（LoA）内。肺功能异常诊断和严重程度分类的Cohen's kappa统计量分别为0.872和0.878。在可用性测试中，30名志愿者中有28名获得了A级结果。
便携式肺功能仪与高质量的实验室肺功能仪表现出很强的相关性和一致性，在肺功能异常诊断和严重程度分类方面也具有一致性。非专业人员使用这款便携式肺功能仪也能获得可接受的结果。
