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可穿戴式肺部监测系统,具备集成的功能性肺部成像和胸部声音记录功能:一项在健康受试者中的临床研究。

Wearable pulmonary monitoring system with integrated functional lung imaging and chest sound recording: a clinical investigation in healthy subjects.

机构信息

University Medical Centre Schleswig-Holstein, Campus Kiel, Department of Anaesthesiology and Intensive Care Medicine, Kiel, Germany.

Smartex s.r.l., Pisa, Italy.

出版信息

Physiol Meas. 2023 Apr 18;44(4). doi: 10.1088/1361-6579/acc82a.

Abstract

Current wearable respiratory monitoring devices provide a basic assessment of the breathing pattern of the examined subjects. More complex monitoring is needed for healthcare applications in patients with lung diseases. A multi-sensor vest allowing continuous lung imaging by electrical impedance tomography (EIT) and auscultation at six chest locations was developed for such advanced application. The aims of our study were to determine the vest's capacity to record the intended bio-signals, its safety and the comfort of wearing in a first clinical investigation in healthy adult subjects.Twenty subjects (age range: 23-65 years) were studied while wearing the vests during a 14-step study protocol comprising phases of quiet and deep breathing, slow and forced full expiration manoeuvres, coughing, breath-holding in seated and three horizontal postures. EIT, chest sound and accelerometer signals were streamed to a tablet using a dedicated application and uploaded to a back-end server. The subjects filled in a questionnaire on the vest properties using a Likert scale.All subjects completed the full protocol. Good to excellent EIT waveforms and functional EIT images were obtained in 89% of the subjects. Breathing pattern and posture dependent changes in ventilation distribution were properly detected by EIT. Chest sounds were recorded in all subjects. Detection of audible heart sounds was feasible in 44%-67% of the subjects, depending on the sensor location. Accelerometry correctly identified the posture in all subjects. The vests were safe and their properties positively rated, thermal and tactile properties achieved the highest scores.The functionality and safety of the studied wearable multi-sensor vest and the high level of its acceptance by the study participants were confirmed. Availability of personalized vests might further advance its performance by improving the sensor-skin contact.

摘要

当前的可穿戴呼吸监测设备可基本评估受检者的呼吸模式。对于肺部疾病患者的医疗保健应用,需要更复杂的监测。为此,我们开发了一种多传感器背心,可通过电阻抗断层成像(EIT)和六个胸部位置听诊对肺部进行连续成像,以满足这种高级应用。我们的研究目的是确定背心记录预期生物信号的能力、其安全性以及在健康成年受检者中首次临床研究中的穿着舒适度。

20 名受检者(年龄范围:23-65 岁)穿着背心,按照包含安静和深呼吸、缓慢和强制完全呼气动作、咳嗽、坐姿和三种水平姿势下屏气等 14 个步骤的研究方案进行研究。EIT、胸部声音和加速度计信号使用专用应用程序流式传输到平板电脑,并上传到后端服务器。受检者使用李克特量表对背心特性填写问卷。

所有受检者均完成了完整方案。89%的受检者获得了良好到优秀的 EIT 波形和功能性 EIT 图像。EIT 可适当检测到与呼吸模式和姿势相关的通气分布变化。所有受检者均记录到胸部声音。取决于传感器位置,可听心音的检测率为 44%-67%。加速度计可正确识别所有受检者的姿势。背心安全且其特性受到积极评价,热和触觉特性获得了最高分。

研究中穿戴式多传感器背心的功能和安全性以及研究参与者对其的高度接受度得到了确认。个性化背心的可用性可能会通过改善传感器与皮肤的接触来进一步提高其性能。

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