Clinical Evaluation of an Automatic Oxygen Control System for Premature Infants Receiving High-Flow Nasal Cannula for Respiratory Support: A Pilot Study.

IF 0.8 4区医学 Q4 ENGINEERING, BIOMEDICAL

Journal of Medical Devices-Transactions of the Asme Pub Date : 2022-09-01 DOI:10.1115/1.4054250

Xuefeng Hou, Akram Faqeeh, Ramak Amjad, John Pardalos, Roger Fales

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Abstract

A pilot clinical study was conducted that compared the peripheral oxygen saturation (SpO₂) targeting performance of an automatic oxygen control system with manual oxygen control, which is the standard of care for preterm and low birth weight infants on high-flow nasal cannula (HFNC). The new oxygen control device studied was used to automatically adjust the fraction of inspired oxygen (FiO₂) according to a desired SpO₂ target setpoint and measured feedback signals including the SpO₂ and other signals. A crossover study was designed with several endpoints including the comparison of the percentage of time that the SpO₂ was within the target range with the automatic oxygen control device versus manual oxygen control. Other metrics were also compared to assess the performance of the system including the number of bradycardia events. The pilot study included six patients that fit the inclusion criteria. The results showed that there were improvements in all of the measured outcomes considered including statistically significant improvements in the number of bradycardia events during the period when the automatic oxygen control device was used.

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早产儿接受高流量鼻插管呼吸支持的自动氧控制系统的临床评价:一项初步研究。

通过一项中试临床研究，比较了高流量鼻插管(HFNC)下早产儿和低出生体重儿护理标准的自动氧控系统与手动氧控系统的外周氧饱和度(SpO2)靶向性能。所研究的新型氧气控制装置可根据所需的SpO2目标设定值和测量的反馈信号(包括SpO2和其他信号)自动调节吸入氧(FiO2)的分数。交叉研究设计了几个终点，包括比较自动氧气控制装置与手动氧气控制装置的SpO2在目标范围内的时间百分比。还比较了其他指标来评估系统的性能，包括心动过缓事件的数量。初步研究包括6名符合纳入标准的患者。结果显示，在使用自动氧气控制装置期间，所有测量结果均有改善，包括在统计学上显著改善心动过缓事件的数量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Medical Devices-Transactions of the Asme ENGINEERING, BIOMEDICAL-

CiteScore

1.80

自引率

11.10%

发文量

审稿时长

6-12 weeks

期刊介绍： The Journal of Medical Devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation. It provides special coverage of novel devices that allow new surgical strategies, new methods of drug delivery, or possible reductions in the complexity, cost, or adverse results of health care. The Design Innovation category features papers focusing on novel devices, including papers with limited clinical or engineering results. The Medical Device News section provides coverage of advances, trends, and events.