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一种用于诊断早产儿酸性和非酸性胃食管反流的新型非侵入性加速度测量方法:概念验证

A New, Noninvasive Accelerometric Method for Diagnosing Acid andNon-Acid Gastroesophageal Reflux in Premature Infants: Proof of Concept.

作者信息

Gewolb Ira H, Vice Frank L

机构信息

Division of Neonatology, Department of Pediatrics and Human Development, Michigan State University College of Human Medicine, East Lansing, MI 48824.

出版信息

J Med Device. 2019 Dec 1;13(4):0445051-445057. doi: 10.1115/1.4044902. Epub 2019 Nov 1.

Abstract

Non-acid reflux is common in premature neonates. Current methods of diagnosing gastroesophageal reflux (GER) such as pH probes, multichannel impedance monitoring, X-rays, or endoscopy are either invasive or unable to diagnose non-acid reflux. Passage of a naso-esophageal tube is uncomfortable. Imaging studies are of short duration and may miss reflux entirely. Herein, we present proof of concept of a noninvasive accelerometric device that detects acid and non-acid reflux in premature infants. An accelerometer was taped over the subxiphoid process in patients suspected of having GER who were already scheduled for pH probe or multichannel impedance monitoring. The largest cohort was preterm infants, but term infants and toddlers were also studied. Low-frequency subaudible signals were obtained on a digital recorder (sampling rate 200 Hz) signals. Fast Fourier transforms graphically displayed the frequency and amplitude of signals. Data were then resampled at a rate of 60 Hz to create a spectrogram with a focused range of 0-30 Hz representing reflux-associated events. Proof of concept was attained through successful comparison with results from concurrent pH probes, multichannel impedance recordings, and ultrasound studies. We have thus validated accelerometry as a noninvasive method for assessing both acid and non-acid GER. The noninvasiveness of this diagnostic modality allows for repeated testing to assess the efficacy of anti-reflux medications, even when patients remain on antacids. This technology allows for more rational management of patients with GER and represents a major advance in the diagnosis and treatment of GER.

摘要

非酸性反流在早产儿中很常见。目前诊断胃食管反流(GER)的方法,如pH探头、多通道阻抗监测、X射线或内窥镜检查,要么具有侵入性,要么无法诊断非酸性反流。插入鼻食管管会让患者感到不适。影像学研究的时间较短,可能会完全错过反流情况。在此,我们展示了一种非侵入性加速度计设备用于检测早产儿酸性和非酸性反流的概念验证。对于疑似患有GER且已安排进行pH探头或多通道阻抗监测的患者,将加速度计贴在剑突下。最大的研究队列是早产儿,但足月儿和幼儿也在研究范围内。在数字记录仪(采样率200Hz)上获取低频次声信号。快速傅里叶变换以图形方式显示信号的频率和幅度。然后将数据以60Hz的速率重新采样,以创建一个频谱图,其聚焦范围为0 - 30Hz,代表与反流相关的事件。通过与同时进行的pH探头、多通道阻抗记录和超声研究结果成功对比,实现了概念验证。我们因此验证了加速度测量法作为一种评估酸性和非酸性GER的非侵入性方法。这种诊断方式的非侵入性允许进行重复测试以评估抗反流药物的疗效,即使患者仍在服用抗酸剂。这项技术有助于对GER患者进行更合理的管理,代表了GER诊断和治疗方面的一项重大进展。

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