Yoo Suyoung, Chang Hansol, Kim Taerim, Yoon Hee, Hwang Sung Yeon, Shin Tae Gun, Sim Min Seob, Jo Ik Joon, Choi Jin-Ho, Cha Won Chul
Department of Digital Health, Samsung Advanced Institute for Health Science & Technology, Sungkyunkwan University, Seoul, Republic of Korea.
Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Interact J Med Res. 2022 Sep 13;11(2):e36335. doi: 10.2196/36335.
In the emergency department (ED), the result obtained using the 12-lead electrocardiography (ECG) is the basis for diagnosing and treating patients with chest pain. It was found that performing ECG at the appropriate time could improve treatment outcomes. Hence, a wearable ECG device with a timer can ensure that the findings are continuously recorded.
We aimed to compare the time accuracy of a single-patch 12-lead ECG (SP-ECG) with that of conventional ECG (C-ECG). We hypothesized that SP-ECG would result in better time accuracy.
Adult patients who visited the emergency room with chest pain but were not in shock were randomly assigned to one of the following 2 groups: the SP-ECG group or the C-ECG group. The final analysis included 33 (92%) of the 36 patients recruited. The primary outcome was the comparison of the time taken by the 2 groups to record the ECG. The average ages of the participants in the SP-ECG and C-ECG groups were 63.7 (SD 18.4) and 58.1 (SD 12.4) years, respectively.
With a power of 0.95 and effect sizes of 0.05 and 1.36, the minimum number of samples was calculated. The minimum sample size for each SP-ECG and C-ECG group is 15.36 participants, assuming a 20% dropout rate. As a result, 36 patients with chest pain participated, and 33 of them were analyzed. The timeliness of SP-ECG and C-ECG for the first follow-up ECG was 87.5% and 47.0%, respectively (P=.74). It was 75.0% and 35.2% at the second follow-up, respectively (P=.71).
Continuous ECG monitoring with minimal interference from other examinations is feasible and essential in complex ED situations. However, the precision of SP-ECG has not yet been proved. Nevertheless, the application of SP-ECG is expected to improve overcrowding and human resource shortages in EDs, though more research is needed.
ClinicalTrials.gov NCT04114760; https://clinicaltrials.gov/ct2/show/NCT04114760.
在急诊科（ED），使用12导联心电图（ECG）获得的结果是胸痛患者诊断和治疗的基础。研究发现，在适当时间进行心电图检查可以改善治疗效果。因此，一种带有定时器的可穿戴式心电图设备可以确保连续记录检查结果。
我们旨在比较单贴片12导联心电图（SP-ECG）与传统心电图（C-ECG）的时间准确性。我们假设SP-ECG将具有更好的时间准确性。
因胸痛就诊于急诊室但未处于休克状态的成年患者被随机分配到以下2组之一：SP-ECG组或C-ECG组。最终分析纳入了招募的36例患者中的33例（92%）。主要结局是比较两组记录心电图所用的时间。SP-ECG组和C-ECG组参与者的平均年龄分别为63.7岁（标准差18.4）和58.1岁（标准差12.4）。
在检验效能为0.95、效应量分别为0.05和1.36的情况下，计算出最小样本量。假设脱落率为20%，SP-ECG组和C-ECG组每组的最小样本量为15.36名参与者。结果，36例胸痛患者参与研究，其中33例进行了分析。首次随访心电图时，SP-ECG和C-ECG的及时性分别为87.5%和47.0%（P = 0.74）。第二次随访时分别为75.0%和35.2%（P = 0.71）。
在复杂的急诊科情况下，进行连续心电图监测且受其他检查干扰最小是可行且必要的。然而，SP-ECG的精确性尚未得到证实。尽管如此，预计SP-ECG的应用将改善急诊科的拥挤状况和人力资源短缺问题，不过仍需要更多研究。
ClinicalTrials.gov NCT04114760；https://clinicaltrials.gov/ct2/show/NCT04114760。
