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Pervasive wearable device for free tissue transfer monitoring based on advanced data analysis: clinical study report

机译:基于高级数据分析的用于免费组织转移监测的普及型可穿戴设备:临床研究报告

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摘要

Free tissue transfer (FTT) surgery for breast reconstruction following mastectomy has become a routine operation with high success rates. Although failure is low, it can have a devastating impact on patient recovery, prognosis, and psychological well-being. Continuous and objective monitoring of tissue oxygen saturation ( ) has been shown to reduce failure rates through rapid detection time of postoperative vascular complications. We have developed a pervasive wearable wireless device that employs near-infrared spectroscopy (NIRS) to continuously monitor FTT via measurement. Previously tested on different models, the results of a clinical study are introduced. Our goal for the study is to demonstrate that the developed device can reliably detect variations in a clinical setting: 14 patients were recruited. Advanced data analysis was performed on the variations, the relative gradient change, and the classification of the within different clusters of blood occlusion level (from 0% to 100% at 25% step) based on previous studies made on a vascular phantom and animals. The outcomes of the clinical study concur with previous experimental results and the expected biological responses. This suggests that the device is able to correctly detect perfusion changes and provide real-time assessment on the viability of the FTT in a clinical setting.
机译:乳房切除术后用于乳房重建的免费组织转移(FTT)手术已成为常规手术,成功率很高。尽管失败率很低,但它可能对患者的康复,预后和心理健康产生毁灭性影响。连续和客观地监测组织氧饱和度()可通过快速检测术后血管并发症的时间来减少失败率。我们已经开发出一种普及型可穿戴无线设备,该设备采用近红外光谱(NIRS)通过测量来连续监视FTT。先前已在不同模型上进行了测试,并介绍了临床研究的结果。我们的研究目标是证明开发出的设备能够可靠地检测临床环境中的变异:招募了14名患者。基于先前对血管模型和动物所做的研究,对血液闭塞水平的不同簇中的变化,相对梯度变化和内部分类(从0%到100%,25%步长)进行了高级数据分析。临床研究的结果与以前的实验结果和预期的生物学反应一致。这表明该设备能够正确检测灌注变化,并在临床环境中提供FTT生存能力的实时评估。

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