Travers Colm P, Nakhmani Arie, Armstead Kimberly M, Benz Rachel L, Foshee Kathryn M, Carlo Waldemar A
Department of Pediatrics, The University of Alabama at Birmingham, Birmingham, Alabama, USA
Department of Electrical and Computer Engineering, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Arch Dis Child Fetal Neonatal Ed. 2025 May 12. doi: 10.1136/archdischild-2025-328540.
To determine the diagnostic accuracy of an over-the-counter infant pulse oximeter for cardiorespiratory events.
Single-centre prospective diagnostic accuracy study.
University of Alabama at Birmingham.
Infants weighing ≥1500 g, <44 weeks' postmenstrual age (PMA) and off ventilator/continuous positive airway pressure support.
Test device for 48 hours in addition to standard hospital monitors, ECG and pulse oximetry.
Data were time aligned and analysed using MATLAB. The coprimary outcomes were the diagnostic accuracy of the test device for the detection of events with heart rate (HR) <50 beats per minute (bpm) and events with oxygen saturations (SpO) <80% for ≥3 s.
66 infants with a median gestational age of 31 weeks (range 23-40) were studied at a median 35 weeks' PMA (range 32-42) weighing 1930 g (range 1500-3605 g) from April to July 2023. The sensitivity for detection of HR <50 bpm ≥3 s was 6% and 39% for smoothed and raw data, respectively, while the specificity was >99% for both smoothed and raw data. The sensitivity for SpO <80% ≥3 s was 14% and 74%, while the specificity was >99% and 96% for smoothed and raw data, respectively. Sensitivity for bradycardia events was higher for events with longer durations and/or when using higher thresholds. Sensitivity was higher for hypoxaemia events with longer durations and/or when using higher thresholds.
An over-the-counter infant pulse oximeter had high specificity for bradycardia and hypoxaemia events consistent with a low false alarm rate. Sensitivity improved with longer events and higher event thresholds.
NCT05774470.
确定一种非处方婴儿脉搏血氧仪对心肺事件的诊断准确性。
单中心前瞻性诊断准确性研究。
阿拉巴马大学伯明翰分校。
体重≥1500克、孕龄<44周且已撤离呼吸机/持续气道正压通气支持的婴儿。
除标准医院监护仪、心电图和脉搏血氧仪外，对测试设备进行48小时监测。
数据进行时间对齐并使用MATLAB分析。共同主要结局是测试设备检测心率（HR）<50次/分钟（bpm）事件和血氧饱和度（SpO）<80%持续≥3秒事件的诊断准确性。
2023年4月至7月，研究了66例婴儿，中位孕龄31周（范围23 - 40周），中位孕龄周数35周（范围32 - 42周），体重1930克（范围1500 - 3605克）。对于检测HR<50 bpm持续≥3秒，平滑数据和原始数据的敏感性分别为6%和39%，而平滑数据和原始数据的特异性均>99%。对于SpO<80%持续≥3秒，敏感性分别为14%和74%，而平滑数据和原始数据的特异性分别为>99%和96%。心动过缓事件持续时间越长和/或使用更高阈值时，敏感性越高。低氧血症事件持续时间越长和/或使用更高阈值时，敏感性越高。
一种非处方婴儿脉搏血氧仪对心动过缓和低氧血症事件具有高特异性，假阳性率低。随着事件持续时间延长和事件阈值提高，敏感性有所改善。
NCT05774470。
