基于柔性材料的贴片式心电仪在临床应用的初步探讨

Clinical application of patch-type electrocardiograph based on flexible materials

目的 以临床常规使用的心电监护仪作为标准,初步探讨我国自主研发的基于柔性材料的贴片式心电仪在诊断 心律失常方面的有效性和安全性。方法 采用单盲、自身对照的试验设计方法,符合入选标准的受试者同时佩戴1 h的贴片式心 电仪和心电监护仪,评价二者心律失常诊断的一致性和临床适用性,同时观察仪器相关不良事件的发生情况。结果 贴片式心 电仪和心电监护仪均检出48例心律失常,心律失常诊断总符合率为1;2种检测方法窦性心动过速,窦性心动过缓,房性早搏,室 上性心动过速,心房颤动,心房扑动,室性心动过速检出率完全一致;贴片式心电仪测量平均心率(74.0±14.7)次/min,心电监 护仪(73.3±14.5)次/min,二者平均差值(0.8±0.7)次/min;贴片式心电仪成功报警历次率为100%,心电数据成功传输成功率为 100%。期间未发现不良事件和其他安全性事件。结论 我国自主研发的基于柔性材料的贴片式心电仪和常规心电监护仪对 心律失常的检出率等效,具有良好的有效性和安全性,能够满足临床应用需要。

Objective To tentatively evaluate the efficacy and safety of China-developed patch-type electrocardiographs(ECGs)based on flexible materials in the diagnosis of arrhythmia compared to the standard ECG monitor. Methods A single-blind, self-controlled trial design method was adopted, involving a one-hour patch-type ECG and standard ECG monitor for inpatients who met the inclusion criteria. Diagnosis and outcome measurement were conducted by an independent third party to evaluate the consistency and clinical applicability of the two instruments in the diagnosis of arrhythmia. Meanwhile, the occurrence of instrument-related adverse events was observed. Results Forty-eight cases of arrhythmia were detected by the patch-type electrocardiograph and electrocardiograph monitor, and the total coincidence rate of arrhythmia diagnosis was 1. The detection rates of sinus tachycardia, sinus bradycardia, atrial premature beat, supraventricular tachycardia, atrial fibrillation, atrial flutter and ventricular tachycardia were identical. The average heart rate (74.0±14.7) times/min was measured by the patch type electrocardiograph and (73.3±14.5) times/min by the electrocardiograph. The difference between the two was (0.8±0.7) times/min. The success rate of the patch type ECG alarm was 100%, and the success rate of ECG data transmission was also 100%. No adverse events and other safety events were found. Conclusion The flexible material-based patch-type ECG developed in China and ECG monitor are equally effective and safe in the detection of arrhythmia, both of which can meet the need of clinical application.