Centre for Human Drug Research, Leiden, The Netherlands.
Juliana Children's Hospital, HAGA Teaching Hospital, The Hague, The Netherlands.
Pediatr Pulmonol. 2020 Sep;55(9):2463-2470. doi: 10.1002/ppul.24932. Epub 2020 Jul 8.
Diagnosis and follow-up of respiratory diseases traditionally rely on pulmonary function tests (PFTs), which are currently performed in hospitals and require trained personnel. Smartphone-connected spirometers, like the Air Next spirometer, have been developed to aid in the home monitoring of patients with pulmonary disease. The aim of this study was to investigate the technical validity and usability of the Air Next spirometer in pediatric patients.
Device variability was tested with a calibrated syringe. About 90 subjects, aged 6 to 16, were included in a prospective cohort study. Fifty-eight subjects performed conventional spirometry and subsequent Air Next spirometry. The bias and the limits of agreement between the measurements were calculated. Furthermore, subjects used the device for 28 days at home and completed a subject-satisfaction questionnaire at the end of the study period.
Interdevice variability was 2.8% and intradevice variability was 0.9%. The average difference between the Air Next and conventional spirometry was 40 mL for forced expiratory volume in 1 second (FEV1) and 3 mL for forced vital capacity (FVC). The limits of agreement were -270 mL and +352 mL for FEV1 and -403 mL and +397 mL for FVC. About 45% of FEV1 measurements and 41% of FVC measurements at home were acceptable and reproducible according to American Thoracic Society/European Respiratory Society criteria. Parents scored difficulty, usefulness, and reliability of the device 1.9, 3.5, and 3.8 out of 5, respectively.
The Air Next device shows validity for the measurement of FEV1 and FVC in a pediatric patient population.
传统上，呼吸系统疾病的诊断和随访依赖于肺功能测试（PFTs），这些测试目前在医院进行，需要经过培训的人员操作。为了帮助肺病患者在家中进行监测，已经开发出了与智能手机相连的肺活量计，如 Air Next 肺活量计。本研究旨在探讨 Air Next 肺活量计在儿科患者中的技术有效性和可用性。
使用校准注射器测试设备变异性。一项前瞻性队列研究纳入了约 90 名年龄在 6 至 16 岁的受试者。其中 58 名受试者进行了常规肺活量计检查和随后的 Air Next 肺活量计检查。计算了测量值之间的偏差和一致性界限。此外，受试者在家中使用该设备 28 天，并在研究结束时完成了一份受试者满意度问卷。
设备间变异性为 2.8%，设备内变异性为 0.9%。Air Next 和常规肺活量计之间的平均差异为 1 秒用力呼气量（FEV1）为 40 毫升，用力肺活量（FVC）为 3 毫升。FEV1 的一致性界限为-270 毫升和+352 毫升，FVC 的一致性界限为-403 毫升和+397 毫升。根据美国胸科学会/欧洲呼吸学会标准，约 45%的 FEV1 测量值和 41%的 FVC 测量值在家庭中是可接受且可重复的。家长对设备的难度、有用性和可靠性的评分分别为 1.9、3.5 和 3.8（满分 5 分）。
Air Next 设备在儿科患者人群中测量 FEV1 和 FVC 具有有效性。
