Department of Pediatrics, Narayana Hrudayalaya, Bangalore, Karnataka, India.
Department of Clinical Research, Narayana Hrudayalaya, Bangalore, Karnataka, India.
Indian J Pediatr. 2023 Nov;90(11):1110-1115. doi: 10.1007/s12098-022-04459-8. Epub 2023 Feb 21.
To evaluate the ability of the Nemocare Raksha (NR), an internet of things (IoT)-enabled device, to continuously monitor vitals for 6 h and its safety in newborns. The accuracy of the device was also compared with the readings from the standard device used in the pediatric ward.
Forty neonates (either gender) weighing ≥ 1.5 kg were included in the study. Heart rate, respiratory rate, body temperature, and oxygen saturation was measured using the NR and compared with standard care devices. Safety was assessed by monitoring for skin changes and local rise in temperature. The neonatal infant pain scale (NIPS) was used to assess pain and discomfort.
A total of 227 h of observations (5.67 h per baby) were obtained. No discomfort or device-related adverse events were noted during the study period. The mean difference between the NR and the standard monitoring was 0.66 (0.42 to 0.90) for temperature (°C); -6.57 (-8.66 to -4.47) for heart rate (bpm); 7.60 (6.52 to 8.68) for respiratory rate (breaths per minute); -0.79 (-1.10 to -0.48) for oxygen saturation (%). The level of agreement analyzed using the intraclass correlation coefficient (ICC) was good for heart rate [ICC 0.77 (0.72 to 0.82); p value < 0.001] and oxygen saturation [ICC 0.80 (0.75 to 0.84); p value < 0.001]; moderate for body temperature [ICC 0.54 (0.36 to 0.60); p value < 0.001] and poor for respiratory rate [ICC 0.30 (0.10 to 0.44); p value 0.002].
The NR was able to seamlessly monitor vital parameters in neonates without any safety concern. The device showed a good level of agreement for heart rate and oxygen saturation among the four parameters measured.
评估 Nemocare Raksha（NR），一种物联网（IoT）启用的设备，连续监测生命体征 6 小时的能力及其在新生儿中的安全性。还比较了设备的准确性与儿科病房使用的标准设备的读数。
纳入了 40 名（无论性别）体重≥1.5kg 的新生儿。使用 NR 测量心率、呼吸频率、体温和血氧饱和度，并与标准护理设备进行比较。通过监测皮肤变化和局部温度升高来评估安全性。使用新生儿疼痛量表（NIPS）评估疼痛和不适。
共获得 227 小时的观察结果（每个婴儿 5.67 小时）。在研究期间，没有注意到不适或与设备相关的不良事件。NR 与标准监测之间的平均差异为：体温（°C）为 0.66（0.42 至 0.90）；心率（bpm）为-6.57（-8.66 至-4.47）；呼吸频率（每分钟呼吸次数）为 7.60（6.52 至 8.68）；血氧饱和度（%）为-0.79（-1.10 至-0.48）。使用组内相关系数（ICC）分析的一致性水平对于心率良好[ICC 0.77（0.72 至 0.82）；p 值<0.001]和血氧饱和度[ICC 0.80（0.75 至 0.84）；p 值<0.001]；体温适中[ICC 0.54（0.36 至 0.60）；p 值<0.001]和呼吸频率差[ICC 0.30（0.10 至 0.44）；p 值 0.002]。
NR 能够无缝监测新生儿的生命体征，无任何安全问题。该设备在测量的四个参数中显示出心率和血氧饱和度的良好一致性水平。
