无线脉搏血氧仪在早产儿或体重<2.5kg 婴儿中的准确性。

Accuracy of Wireless Pulse Oximeter on Preterm or <2.5 kg Infants.

机构信息

Division of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.

Department of Statistics, University of Utah, Salt Lake City, Utah.

出版信息

Am J Perinatol. 2024 May;41(S 01):e1606-e1612. doi: 10.1055/s-0043-1768068. Epub 2023 Apr 18.

DOI:10.1055/s-0043-1768068

PMID:37072015

Abstract

OBJECTIVE

Monitoring heart rate (HR) and oxygen saturation (SpO) in infants is essential in the neonatal intensive care unit. Wireless pulse oximeter technology has been advancing but with limited accuracy data on preterm infants. This observational study compared HR and SpO of the wireless Owlet Smart Sock 3 (OSS3) to the wired Masimo SET (Masimo) pulse oximeter in preterm or <2.5 kg infants.

STUDY DESIGN

Twenty-eight eligible infants were enrolled. They weighed between 1.7 and 2.5 kg and were without anomalies or medical instability. OSS3 and Masimo simultaneously monitored HR and SpO for 60 minutes. The data were aligned by time epoch and filtered for poor tracings. The agreement was compared using the Pearson's correlation coefficient, the Bland-Altman method, average root mean square (ARMS), and prevalence and bias adjusted kappa (PABAK) analyses.

RESULTS

Two infants' data were excluded due to motion artifacts or device failures. The corrected gestational age and current weights were 35 ± 3 weeks and 2.0 ± 0.2 kg (mean ± standard deviation), respectively. Over 21 hours of data showed that HR was strongly correlated between the two devices ( = 0.98, < 0.001), with a difference of -1.3 beats per minute (bpm) and the limit of agreement (LOA) -6.3 to 3.4 bpm based on the Bland-Altman method. SpO was positively correlated between the two devices ( = 0.71, < 0.001) with a SpO bias of 0.3% (LOA: -4.6 to 4.5%). The estimated ARMS of OSS3 compared with Masimo was 2.3% for SpO in the 70 to 100% range. The precision decreased with lower SpO. A strong agreement (PABAK = 0.94) was between the two devices on whether SpO was above or below 90%.

CONCLUSION

OSS3 provided comparable HR and SpO accuracy to Masimo in preterm or <2.5 kg infants. Motion artifacts, lack of arterial blood gas comparisons, and lack of racial and ethnic diversity are the study limitations. More OSS3 data on the Lower HR and SpO ranges were needed before implementing inpatient use.

KEY POINTS

· Pulse oximeters are vital for monitoring preterm infants' HR and SpO2 levels.. · Limited data exist on the accuracy of the wireless OSS3 on preterm infants.. · This observational study found that the OSS3 is comparable to the Masimo SET in measuring HR and SpO2 in preterm or <2.5 kg infants..

摘要

目的

在新生儿重症监护病房中，监测婴儿的心率（HR）和血氧饱和度（SpO2）至关重要。无线脉搏血氧仪技术不断发展，但早产儿的准确性数据有限。本观察性研究比较了无线 Owlet Smart Sock 3（OSS3）和有线 Masimo SET（Masimo）脉搏血氧仪在早产儿或体重<2.5kg 婴儿中的 HR 和 SpO。

研究设计

共纳入 28 名符合条件的婴儿。他们的体重在 1.7 至 2.5kg 之间，无畸形或无医学不稳定。OSS3 和 Masimo 同时监测 HR 和 SpO2 60 分钟。通过时间epoch 对齐数据，并对不良轨迹进行过滤。使用 Pearson 相关系数、Bland-Altman 方法、平均均方根（ARMS）以及流行率和偏差调整kappa（PABAK）分析比较一致性。

结果

由于运动伪影或设备故障，有两名婴儿的数据被排除。校正胎龄和当前体重分别为 35±3 周和 2.0±0.2kg（平均值±标准差）。在 21 小时的数据中，HR 在两个设备之间呈强相关性（r=0.98，<0.001），差异为-1.3 次/分钟（bpm），Bland-Altman 法的界限为-6.3 至 3.4 bpm。SpO 在两个设备之间呈正相关（r=0.71，<0.001），SpO 偏差为 0.3%（LOA：-4.6 至 4.5%）。与 Masimo 相比，OSS3 的估计 ARMS 为 SpO 在 70%至 100%范围内的 2.3%。SpO 越低，精度越低。两个设备之间在 SpO 是否高于或低于 90%时具有很强的一致性（PABAK=0.94）。