在早期皮肤接触时，心电图与新的无线设备之间的心率一致性。
Heart-rate agreement between ECG and a new, wireless device during early skin-to-skin contact.
机构信息
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Neonatal Intensive Care Unit, Milan, Italy.
Division of Biostatistics, Department of Statistics and Quantitative Methods, Epidemiology and Public Health, University of Milano-Bicocca, Milan, Italy.
出版信息
Acta Paediatr. 2021 Jun;110(6):1803-1809. doi: 10.1111/apa.15769. Epub 2021 Jan 31.
AIM
To assess the agreement of heart rate (HR) between the new device - a fabric jacket for neonates, with integrated sensors detecting ECG signals and a Bluetooth connection to a computer (ComfTech, HOWDY) - and the clinical reference, ECG, during the skin-to-skin contact (SSC) in the first 2 h after birth, for the potential use of early detection of Sudden and Unexpected Postnatal Collapse (SUPC).
METHODS
We enrolled newborns ≥35 weeks of gestation, with Apgar score >8 at 5 min in a prospective, observational study in the delivery room, excluding infants with need for resuscitation, clinical instability or major malformations. We assessed HR within 20 min after birth by both devices simultaneously: the index test ComfTech HOWDY and the standard ECG (Vita Guard VG 3100, Getemed). We compared HR between the two methods at 0, 15, 30, 45, 60, 90 and 120 min by the Bland-Altman plot.
RESULTS
We included 60 infants. The mean difference between the methods was -1.3 bpm, 95%LoA -12.4 to 9.7 bpm. Spearman rank correlation coefficient ρ = -0.06.
CONCLUSION
ComfTech HOWDY presents reliable agreement with the ECG and might assist in identifying infants at risk for SUPC.
目的
评估新设备——一种带有集成传感器的新生儿织物外套，可检测心电图信号并通过蓝牙连接到计算机（ComfTech，HOWDY）——与临床参考心电图在出生后 2 小时内皮肤接触（SSC）期间心率（HR）的一致性，以便有潜力用于早期检测新生儿猝死后意外综合征（SUPC）。
方法
我们在产房进行了一项前瞻性观察研究，纳入了胎龄≥35 周且 5 分钟时 Apgar 评分>8 的新生儿，排除了需要复苏、临床不稳定或有重大畸形的婴儿。我们通过同时使用两种设备（ComfTech HOWDY 和标准心电图（Vita Guard VG 3100，Getemed））在出生后 20 分钟内评估 HR。我们通过 Bland-Altman 图比较了两种方法在 0、15、30、45、60、90 和 120 分钟时的 HR。
结果
我们纳入了 60 名婴儿。两种方法之间的平均差异为-1.3 bpm，95%置信区间（LoA）为-12.4 至 9.7 bpm。Spearman 秩相关系数ρ=-0.06。
结论
ComfTech HOWDY 与心电图具有可靠的一致性，可能有助于识别有发生 SUPC 风险的婴儿。
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