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不同传感器在极早产儿中脉搏血氧仪读数的随机交叉研究。

Randomised crossover study on pulse oximeter readings from different sensors in very preterm infants.

机构信息

Department of Pediatrics, Center for Pediatric Clinical Studies (CPCS), University Hospital Tübingen, Tübingen, Germany.

Department of Neonatology, Tübingen University Hospital, Tübingen, Germany.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):391-396. doi: 10.1136/archdischild-2023-325961.

Abstract

OBJECTIVE

In extremely preterm infants, different target ranges for pulse oximeter saturation (SpO) may affect mortality and morbidity. Thus, the impact of technical changes potentially affecting measurements should be assessed. We studied SpO readings from different sensors for systematic deviations.

DESIGN

Single-centre, randomised, triple crossover study.

SETTING

Tertiary neonatal intensive care unit.

PATIENTS

24 infants, born at <32 weeks' gestation, with current weight <1500 g and without right-to-left shunt via a patent ductus arteriosus.

INTERVENTIONS

Simultaneous readings from three SpO sensors (Red Diamond (RD), Photoplethysmography (PPG), Low Noise Cabled Sensors (LNCS)) were logged at 0.5 Hz over 6 hour/infant and compared with LNCS as control using analysis of variance. Sensor position was randomly allocated and rotated every 2 hours. Seven different batches each were used.

OUTCOMES

Primary outcome was the difference in SpO readings. Secondary outcomes were differences between sensors in the proportion of time within the SpO-target range (90-95 (100)%).

RESULTS

Mean gestational age at birth (±SD) was 27 (±2) weeks, postnatal age 20 (±20) days. 134 hours of recording were analysed. Mean SpO (±SD) was 94.0% (±3.8; LNCS) versus 92.2% (±4.0; RD; p<0.0001) and 94.5% (±3.9; PPG; p<0.0001), respectively. Mean SpO difference (95% CI) was -1.8% (-1.9 to -1.8; RD) and 0.5% (0.4 to 0.5; PPG). Proportion of time in target was significantly lower with RD sensors (84.8% vs 91.7%; p=0.0001) and similar with PPG sensors (91.1% vs 91.7%; p=0.63).

CONCLUSION

There were systematic differences in SpO readings between RD sensors versus LNCS. These findings may impact mortality and morbidity of preterm infants, particularly when aiming for higher SpO-target ranges (eg, 90-95%).

TRIAL REGISTRATION NUMBER

DRKS00027285.

摘要

目的

在极早产儿中,脉搏血氧饱和度(SpO2)的不同目标范围可能会影响死亡率和发病率。因此,应评估可能影响测量的技术变化的影响。我们研究了不同传感器的 SpO2 读数,以确定其系统偏差。

设计

单中心、随机、三交叉研究。

地点

三级新生儿重症监护病房。

患者

24 名胎龄<32 周、当前体重<1500g 且无动脉导管未闭右向左分流的婴儿。

干预措施

同时记录来自三个 SpO2 传感器(Red Diamond(RD)、光体积描记法(PPG)、低噪声有线传感器(LNCS))的读数,每 0.5Hz 记录 6 小时/婴儿,并使用方差分析将结果与 LNCS 作为对照进行比较。传感器位置随机分配,并每 2 小时旋转一次。每个传感器使用了七个不同批次。

主要结局

SpO2 读数的差异为主要结局。次要结局为传感器在 SpO2 目标范围内的时间比例(90-95%(100)%)的差异。

结果

出生时的平均胎龄(±标准差)为 27(±2)周,出生后年龄为 20(±20)天。共分析了 134 小时的记录。平均 SpO2(±标准差)为 94.0%(±3.8;LNCS)、92.2%(±4.0;RD;p<0.0001)和 94.5%(±3.9;PPG;p<0.0001)。SpO2 平均差值(95%CI)为-1.8%(-1.9 至-1.8;RD)和 0.5%(0.4 至 0.5;PPG)。RD 传感器的目标范围内时间比例明显较低(84.8%比 91.7%;p=0.0001),而 PPG 传感器的时间比例相似(91.1%比 91.7%;p=0.63)。

结论

RD 传感器与 LNCS 相比,SpO2 读数存在系统差异。这些发现可能会影响早产儿的死亡率和发病率,尤其是当目标 SpO2 范围较高(例如,90-95%)时。

试验注册号

DRKS00027285。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6640/11228211/d07b6769d8ed/fetalneonatal-2023-325961f01.jpg

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