Accuracy of a portable pulse oximeter in monitoring hypoxemic infants with cyanotic heart disease
Accuracy of a portable pulse oximeter in monitoring hypoxemic infants with cyanotic heart disease
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DOI：
10.1017/s1047951119001355
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发表时间：
2019-08-01
影响因子：
1
通讯作者：
Ramamoorthy, Chandra
中科院分区：
文献类型：
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作者：
Harris, Bronwyn U.;Stewart, Sarah;Ramamoorthy, Chandra
目的：单心室婴儿的动脉血氧饱和度在75%到85%之间。每日脉搏血氧仪家庭监测与改善期间生存率相关。他们通常会带着昂贵、笨重的医院级脉搏血氧仪回家。本研究通过与金标准一氧化碳血氧仪进行比较，评估了目前使用的Masimo LNCS和相对便宜的便携式蓝牙技术研究设备的准确性。设计：前瞻性、观察性研究。设置：单一机构，儿科心脏重症监护病房和新生儿ICU。发言：无。患者：24名12个月以下的婴儿，由于紫绀型CHD，基线血氧饱和度低于90%。测量和结果：使用WristOx（2）3150（带婴儿传感器8008 J）（研究器械）和Masimo LCNS饱和度传感器连接Philips监护仪（医院器械）同时测量脉搏血氧饱和度，并与通过一氧化碳血氧饱和度测定法测量的动脉血氧饱和度进行比较。统计分析评价了每种方法的性能，并与采用Schuirmann's TOST等效性检验的一氧化碳血氧测定法进行了比较，等效性定义为饱和度绝对差小于等于5%。研究器械的阅读平均比一氧化碳血氧仪高4.0%，未能显示统计学等效性（p = 0.16）。医院器械比一氧化碳血氧仪高7.4%，也不符合预定义的等同性标准（p = 0.97）。结论：与金标准一氧化碳血氧测定法相比，两种器械均倾向于高估该患者人群的血氧饱和度。研究器械至少与医院器械一样准确，并且具有蓝牙技术更便携的优势，允许可靠、有效的数据传输。目前FDA批准的小型便携式脉搏血氧仪可以考虑用于家庭监测计划。
Objective: Infants with single ventricle physiology have arterial oxygen saturations between 75 and 85%. Home monitoring with daily pulse oximetry is associated with improved interstage survival. They are typically sent home with expensive, bulky, hospital-grade pulse oximeters. This study evaluates the accuracy of both the currently used Masimo LNCS and a relatively inexpensive, portable, and equipped with Bluetooth technology study device, by comparing with the gold standard co-oximeter. Design: Prospective, observational study. Setting: Single institution, paediatric cardiac critical care unit, and neonatal ICU. Interventions: none. Patients: Twenty-four infants under 12 months of age with baseline oxygen saturation less than 90% due to cyanotic CHD. Measurements and Results: Pulse oximetry with WristOx(2) 3150 with infant sensors 8008 J (study device) and Masimo LCNS saturation sensor connected to a Philips monitor (hospital device) were measured simultaneously and compared to arterial oxyhaemoglobin saturation measured by co-oximetry. Statistical analysis evaluated the performances of each and compared to co-oximetry with Schuirmann's TOST equivalence tests, with equivalence defined as an absolute difference of 5% saturation or less. Neither the study nor the hospital device met the predefined standard for equivalence when compared with co-oximetry. The study device reading was on average 4.0% higher than the co-oximeter, failing to show statistical equivalence (p = 0.16). The hospital device was 7.4% higher than the co-oximeter and also did not meet the predefined standard for equivalence (p = 0.97). Conclusion: Both devices tended to overestimate oxygen saturation in this patient population when compared to the gold standard, co-oximetry. The study device is at least as accurate as the hospital device and offers the advantage of being more portable with Bluetooth technology that allows reliable, efficient data transmission. Currently FDA-approved, smaller portable pulse oximeters can be considered for use in home monitoring programmes.