Department of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada
Department of Pediatrics, Aga Khan University, Nairobi, Kenya.
Arch Dis Child. 2022 Jun;107(6):558-564. doi: 10.1136/archdischild-2021-322344. Epub 2021 Nov 5.
Globally, 2.5 million neonates died in 2018, accounting for 46% of under-5 deaths. Multiparameter continuous physiological monitoring (MCPM) of neonates allows for early detection and treatment of life-threatening health problems. However, neonatal monitoring technology is largely unavailable in low-resource settings.
In four evaluation rounds, we prospectively compared the accuracy of the EarlySense under-mattress device to the Masimo Rad-97 pulse CO-oximeter with capnography reference device for heart rate (HR) and respiratory rate (RR) measurements in neonates in Kenya. EarlySense algorithm optimisations were made between evaluation rounds. In each evaluation round, we compared 200 randomly selected epochs of data using Bland-Altman plots and generated Clarke error grids with zones of 20% to aid in clinical interpretation.
Between 9 July 2019 and 8 January 2020, we collected 280 hours of MCPM data from 76 enrolled neonates. At the final evaluation round, the EarlySense MCPM device demonstrated a bias of -0.8 beats/minute for HR and 1.6 breaths/minute for RR, and normalised spread between the 95% upper and lower limits of agreement of 6.2% for HR and 27.3% for RR. Agreement between the two MCPM devices met the a priori-defined threshold of 30%. The Clarke error grids showed that all observations for HR and 197/200 for RR were within a 20% difference.
Our research indicates that there is acceptable agreement between the EarlySense and Masimo MCPM devices in the context of large within-subject variability; however, further studies establishing cost-effectiveness and clinical effectiveness are needed before large-scale implementation of the EarlySense MCPM device in neonates.
NCT03920761.
2018 年，全球有 250 万新生儿死亡，占 5 岁以下儿童死亡人数的 46%。多参数连续生理监测（MCPM）可早期发现并治疗危及生命的健康问题。然而，新生儿监测技术在资源匮乏的环境中尚未得到广泛应用。
我们在四轮评估中，前瞻性比较了肯尼亚新生儿的 EarlySense 床垫下设备与 Masimo Rad-97 脉搏 CO-oximeter 带帽二氧化碳描记法参考设备测量心率（HR）和呼吸频率（RR）的准确性。在评估轮次之间，EarlySense 算法进行了优化。在每一轮评估中，我们使用 Bland-Altman 图比较了 200 个随机选择的数据段，并生成 Clarke 误差网格，其中包括 20%的区域，以帮助临床解释。
2019 年 7 月 9 日至 2020 年 1 月 8 日，我们从 76 名入组新生儿中收集了 280 小时的 MCPM 数据。在最后一轮评估中，EarlySense MCPM 设备显示 HR 的偏差为-0.8 次/分钟，RR 的偏差为 1.6 次/分钟，95%上下限的归一化差值为 HR 为 6.2%，RR 为 27.3%。两种 MCPM 设备之间的一致性符合预先设定的 30%的阈值。Clarke 误差网格显示，HR 的所有观察值和 RR 的 197/200 个观察值都在 20%的差异范围内。
我们的研究表明，在个体内变异性较大的情况下，EarlySense 和 Masimo MCPM 设备之间存在可接受的一致性；然而，在大规模实施 EarlySense MCPM 设备之前，还需要进一步的研究来确定其成本效益和临床效果。
NCT03920761。
