Gosser Caroline Emily, Daniel Luther, Huecker Martin, Cavallazzi Rodrigo, Rivas Hiram, Thomas Jarred Jeremy, Close Ryan
Department of Emergency Medicine, University of Louisville, Louisville, KY 40290, USA.
Department of Internal Medicine, University of Louisville, Louisville, KY 40290, USA.
Diagnostics (Basel). 2025 Jun 18;15(12):1550. doi: 10.3390/diagnostics15121550.
Chronic obstructive pulmonary disease (COPD) remains a condition with high morbidity, mortality, and misdiagnosis. The gold standard pulmonary function testing with spirometry has limited availability. This study seeks to test a novel diagnostic test based on auscultatory mapping of pulmonary dynamics. This NIH-funded study aimed to develop a COPD detection technology, using mobile phone auscultation, for situations in which spirometry is not available. This prospective study collected mobile phone auscultation data on patients presenting for spirometry and evaluation by a pulmonologist. All subjects had same-day or recent (less than 6 months) spirometry in one PFT laboratory. After informed consent, the subjects underwent respiratory auscultation using a selection of mobile phone brands. The auscultation methods included normal breathing observed at the left axillary site and egophony observed at the right supra clavicular fossa. The team created models from the recordings using Time Series Dynamics (TSD), proprietary software that uses computational nonlinear dynamics to characterize the respiratory biofluid dynamics implied by the acoustic data. We enrolled a total of 108 patients (34.3% male), from 19 to 85 years of age (median 61 years). Among the patients, 64 (59.3%) subjects identified as White, 43 (39.8%) as Black, and 1 as Asian. Among the two cohorts with diverse comorbidities, 52 subjects had confirmed COPD and 56 did not. The cohorts differed significantly in age and body mass index, but not in race, number of comorbidities, or COPD assessment test scores. They had significant differences in forced expiratory volume in 1 s (FEV1), the FEV1/FVC (forced vital capacity) ratio, but not FVC. The recordings from the egophonic and axillary sites were initially modeled separately and then combined in a single composite model. The modeling produced excellent results with 90%+ AUC and sensitivity in both the test and train sets relative to the gold standard. Evidence suggests that a mobile phone auscultation device can accurately determine COPD diagnosis. In frontline applications where the availability of gold standard pulmonary function testing is limited, the device could improve the detection of COPD, a condition with significant over- and under-diagnosis. Future trials will investigate the ability of patients to self-record. Success would support remote COPD testing using transmitted telehealth recording data, bringing diagnosis to patients in underserved populations.
慢性阻塞性肺疾病(COPD)仍然是一种发病率、死亡率和误诊率都很高的疾病。肺活量测定这一肺功能测试的金标准,其可用性有限。本研究旨在测试一种基于肺部动力学听诊图谱的新型诊断测试。这项由美国国立卫生研究院资助的研究旨在开发一种用于在无法进行肺活量测定的情况下检测慢性阻塞性肺疾病的技术,即使用手机听诊。这项前瞻性研究收集了前来进行肺活量测定并由肺科医生进行评估的患者的手机听诊数据。所有受试者均在一个肺功能测试实验室进行了当日或近期(不到6个月)的肺活量测定。在获得知情同意后,受试者使用多种手机品牌进行了呼吸听诊。听诊方法包括在左腋窝处观察正常呼吸以及在右锁骨上窝观察羊鸣音。研究团队使用时间序列动力学(TSD)从录音中创建模型,TSD是一种专有软件,它使用计算非线性动力学来表征声学数据所隐含的呼吸生物流体动力学。我们共招募了108名患者(男性占34.3%),年龄在19岁至85岁之间(中位数为61岁)。在这些患者中,64名(59.3%)为白人,43名(39.8%)为黑人,1名是亚洲人。在两个患有不同合并症的队列中,52名受试者被确诊患有慢性阻塞性肺疾病,56名没有。这两个队列在年龄和体重指数上有显著差异,但在种族、合并症数量或慢性阻塞性肺疾病评估测试分数方面没有差异。他们在1秒用力呼气量(FEV1)、FEV1/用力肺活量(FVC)比值上有显著差异,但在用力肺活量(FVC)上没有差异。最初分别对羊鸣音和腋窝部位的录音进行建模,然后将其合并到一个单一的复合模型中。相对于金标准,该模型在测试集和训练集中均产生了优异的结果,曲线下面积(AUC)和灵敏度均超过90%。有证据表明,手机听诊设备可以准确地确定慢性阻塞性肺疾病的诊断。在金标准肺功能测试可用性有限的一线应用中,该设备可以改善慢性阻塞性肺疾病的检测,这种疾病存在大量的过度诊断和诊断不足情况。未来的试验将研究患者自我记录的能力。如果成功,将支持使用传输的远程医疗记录数据进行远程慢性阻塞性肺疾病检测,为服务不足人群的患者带来诊断。