物联网便携式肺功能检测仪的研制与临床应用  

Development of an internet-of-things based portable spirometer and the validation of its accuracy

作　　者：周磊 姜燕 杜春玲 赖国祥[3] 杨达伟[4] 陈玲玲 张惠荣 黄艺聪 文文[3] 刘玮[3] 宋元林 白春学[4] Zhou Lei;Jiang Yan;Du Chunling;Lai Guoxiang;Yang Dawei;Chen Lingling;Zhang Huirong;Huang Yicong;Wen Wen;Liu Wei;Song Yuanlin;Bai Chunxue(Department of Pulmonary and Critical Care Medicine,Zhongshan Hospital,Qingpu Branch, Fudan University,Shanghai 201700,China;Department of Respiratory Medicine,Xiamen Haicang Hospital,Xiamen 361026,China;Department of Respiratory Medicine,Fuzhou General Hospital of Nanjing Military Command,Fuzhou 350001,China;Department of Pulmonary and Critical Care Medicine,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Xeek (Xiamen)Medical Equipment Co.Ltd.,Xiamen 361026,China)

机构地区：[1]复旦大学附属中山医院青浦分院呼吸与危重病科,上海201700 [2]厦门市海沧医院呼吸内科,361026 [3]解放军南京军区福州总医院呼吸内科,350001 [4]复旦大学附属中山医院呼吸与危重病科,上海200032 [5]赛客(厦门)医疗器械有限公司,厦门361026

出　　处：《国际呼吸杂志》2019年第2期113-118,共6页International Journal of Respiration

基　　金：上海市卫生和计划生育委员会重点项目(201540370).

摘　　要：目的为实现呼吸慢性疾病的早期筛查与预防以及慢性阻塞性肺疾病(COPD)的实时监控与管理,研发了一款物联网便携式肺功能检测仪,并测试该肺功能仪的准确性。方法该仪器采用压差式流量传感器测量。采用基于Android操作系统的智能应用软件APP,实现对COPD患者的动态实时监控与管理。首先与ATS标准测试波形及耶格标准肺功能仪进行波形对比,然后纳入了980例受试者分别进行便携式和耶格肺功能仪检测,分析两台仪器检测数据的相关性;采用随机数字表法确定患者接受试验或对照仪器的先后顺序。结果波形对比测试结果显示,实验仪器波形和测试数据与标准波形一致性高。980例受试者的测试数据与标准肺功能仪具有显著的线性相关性。测试指标用力呼气容积(FVC)、呼气峰值流速、第1秒用力呼气容积(FEV1)、FEV1/FVC的相关系数r值分别是0.984、0.985、0.982、0.941。一致性界线图显示,超过95%的受试者检测数据落在一致性界线范围内。结论本研究的测试结果表明,该仪器的测量精准度高,适用于各医疗机构进行肺功能参数检测和COPD患者筛查。其物联网功能可用于COPD患者的长期远程管理。Objective To develop an IOT based handheld portable spirometer and evaluate its accuracy for the purpose of the early diagnosis, real-time monitoring and management of chronic obstructive pulmonary disease (COPD).Methods A pressure differential flow sensor and an Android operating system based APP were employed in this instrument.Compared the expiration waveform with the ATS standard test and Jaeger spirometer.Then enrolled 980 healthy subjects to evaluate the accuracy of the portable spirometer taking the Jaeger spirometer as the contrast.The test order of the instruments was decided randomly.Results The waveforms of portable spirometer were highly consistent with the waveforms of ATS and Jaeger spirometer.The test data of the 980 healthy subjects showed high correlation between the experimental and contrast instruments.The r value of forced vital capacity (FVC), peak expiratory flow (PEF), forced expiratory volume in one second (FEV1), FEV1/FVC were 0.984, 0.985, 0.982 and 0.941 by Pearson correlation analysis, respectively.Consistency boundary map showed more than 95% subjects′ FVC, PEF, FEV1 results located in the consistency boundary.Conclusions The results of this study show that the accuracy of this IOT bases portable spirometer is high enough to meet the demand for pulmonary function test of various medical institutions, and is especially suitable for the COPD patients screening and long term remote management.

关 键 词：肺疾病 慢性阻塞性 物联网 肺功能检测仪 流量传感器 压差式 

分 类 号：TH789[机械工程—仪器科学与技术]