比较一种便携式、基于气流传感器的肺量计（Spirofy™）与 vitalograph alpha Touch™ 肺量计在评估健康个体、哮喘患者和 COPD 患者肺功能方面的性能：一项随机、交叉研究。
Comparison of a portable, pneumotach flow-sensor-based spirometer (Spirofy™) with the vitalograph alpha Touch™ spirometer in evaluating lung function in healthy individuals, asthmatics, and COPD patients-a randomized, crossover study.
机构信息
Department of Pulmonology, Pulmonary Sleep & Critical Care, Metro Centre for Respiratory Diseases, WASOG Sarcoid Clinic, Noida, Uttar Pradesh, India.
Department of Pulmonology, Chest & Diabetes Research Institute, Chennai, Tamil Nadu, India.
出版信息
BMC Pulm Med. 2024 May 10;24(1):230. doi: 10.1186/s12890-024-02972-4.
BACKGROUND
Spirofy™ is India's first portable, pneumotach flow-sensor-based digital spirometer developed to diagnose asthma and chronic obstructive pulmonary disease (COPD). In this study, we compared the performance of the Spirofy™ device with that of the Vitalograph Alpha Touch™ spirometer in measuring the lung capacities of healthy individuals, asthmatics, and COPD patients. We also assessed the inter-device variability between two Spirofy™ devices.
METHODS
In a randomized, three-way crossover, open-label study, we measured the differences in forced expiratory volume in the first second (FEV) and forced vital capacity (FVC) between the Spirofy™ and Vitalograph Alpha Touch™ spirometers. A proportion of the FEV/FVC ratio distribution of < 0.7 was used to compare the diagnostic accuracies of the Spirofy™ with Vitalograph™ Alpha Touch™ spirometers.
RESULTS
Ninety subjects participated in this study. The mean ± SD FVC values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 2.60 ± 1.05 L, 2.64 ± 1.04 L, and 2.67 ± 1.04 L, respectively. The mean ± SD FEV values obtained from the Spirofy™ 1, Spirofy™ 2, and Vitalograph Alpha Touch™ devices were 1.87 ± 0.92 (L), 1.88 ± 0.92 (L), and 1.93 ± 0.93 (L), respectively. A significant positive correlation was found between the FVC and FEV values recorded by Vitalograph Alpha Touch™, Spirofy™ 1, and Spirofy™ 2. As compared to Vitalograph Alpha Touch™, the Spirofy™ device showed good sensitivity (97%), specificity (90%), and overall accuracy (93.3%) at an FEV/FVC ratio < 0.7. No inter-device variability was observed between the two Spirofy™ devices.
CONCLUSION
Spirofy™ is a portable and easy-to-use device and is as accurate as the standard Vitalograph Alpha Touch™ spirometer for the diagnosis of COPD and asthma.
TRIAL REGISTRATION
CTRI/2021/09/036492 (Clinical Trials Registry - India).
背景
Spirofy™ 是印度首款便携式、基于气动流量传感器的数字肺活量计，旨在诊断哮喘和慢性阻塞性肺疾病（COPD）。在这项研究中，我们比较了 Spirofy™ 设备与 Vitalograph Alpha Touch™ 肺活量计在测量健康个体、哮喘患者和 COPD 患者肺容量方面的性能。我们还评估了两台 Spirofy™ 设备之间的设备间可变性。
方法
在一项随机、三向交叉、开放标签研究中，我们测量了 Spirofy™ 和 Vitalograph Alpha Touch™ 肺活量计之间第一秒用力呼气量（FEV）和用力肺活量（FVC）的差异。使用 < 0.7 的 FEV/FVC 比值分布来比较 Spirofy™ 与 Vitalograph™ Alpha Touch™ 肺活量计的诊断准确性。
结果
90 名受试者参加了这项研究。Spirofy™ 1、Spirofy™ 2 和 Vitalograph Alpha Touch™ 设备获得的平均 ± 标准差 FVC 值分别为 2.60 ± 1.05 L、2.64 ± 1.04 L 和 2.67 ± 1.04 L。Spirofy™ 1、Spirofy™ 2 和 Vitalograph Alpha Touch™ 设备获得的平均 ± 标准差 FEV 值分别为 1.87 ± 0.92（L）、1.88 ± 0.92（L）和 1.93 ± 0.93（L）。Vitalograph Alpha Touch™、Spirofy™ 1 和 Spirofy™ 2 记录的 FVC 和 FEV 值之间存在显著的正相关。与 Vitalograph Alpha Touch™ 相比，Spirofy™ 设备在 FEV/FVC 比值 < 0.7 时显示出良好的敏感性（97%）、特异性（90%）和总准确性（93.3%）。两台 Spirofy™ 设备之间没有观察到设备间可变性。
结论
Spirofy™ 是一种便携式、易于使用的设备，与标准的 Vitalograph Alpha Touch™ 肺活量计一样准确，可用于诊断 COPD 和哮喘。
试验注册
CTRI/2021/09/036492（印度临床试验注册处）。
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