Huh Ki Young, Jeong Sae Im, Yoo Hyounggyoon, Piao Meihua, Ryu Hyeongju, Kim Heejin, Yoon Young-Ran, Seong Sook Jin, Lee SeungHwan, Kim Kyung Hwan
Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Seoul National University Hospital, Seoul 03080, Korea.
Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University, Seongnam 13496, Korea.
Transl Clin Pharmacol. 2022 Jun;30(2):87-98. doi: 10.12793/tcp.2022.30.e7. Epub 2022 May 24.
Although wearable electrocardiograms (ECGs) are being increasingly applied in clinical settings, validation methods have not been standardized. As an exploratory evaluation, we performed a multicenter clinical trial implementing an approved wearable patch ECG. Healthy male adults were enrolled in 2 study centers. The approved ECGs were deployed for 6 hours, and pulse rates were measured independently with conventional pulse oximetry at selected time points for correlation analyses. The transmission status of the data was evaluated by heart rates and classified into valid, invalid, and missing. A total of 55 subjects (40 in center 1 and 15 in center 2) completed the study. Overall, 77.40% of heart rates were within the valid range. Invalid and missing data accounted for 1.42% and 21.23%, respectively. There were significant differences in valid and missing data between centers. The proportion of missing data in center 1 (24.77%) was more than twice center 2 (11.77%). Heart rates measured by the wearable ECG and conventional pulse oximetry showed a poor correlation (intraclass correlation coefficient = 0.0454). In conclusion, we evaluated the multicenter feasibility of implementing wearable ECGs. The results suggest that systems to mitigate multicenter discrepancies and remove artifacts should be implemented prior to performing a clinical trial.
ClinicalTrials.gov Identifier: NCT05182684.
尽管可穿戴心电图（ECG）在临床环境中的应用越来越广泛，但验证方法尚未标准化。作为一项探索性评估，我们进行了一项多中心临床试验，采用了一种已获批准的可穿戴式贴片心电图设备。健康成年男性参与了2个研究中心的研究。将已获批准的心电图设备佩戴6小时，并在选定时间点使用传统脉搏血氧饱和度仪独立测量脉搏率以进行相关性分析。通过心率评估数据传输状态，并将其分为有效、无效和缺失。共有55名受试者（中心1有40名，中心2有15名）完成了研究。总体而言，77.40%的心率处于有效范围内。无效数据和缺失数据分别占1.42%和21.23%。各中心之间的有效数据和缺失数据存在显著差异。中心1的缺失数据比例（24.77%）是中心2（11.77%）的两倍多。可穿戴心电图设备测量的心率与传统脉搏血氧饱和度仪测量的心率之间相关性较差（组内相关系数=0.0454）。总之，我们评估了实施可穿戴心电图设备的多中心可行性。结果表明，在进行临床试验之前，应实施减少多中心差异和消除伪影的系统。
ClinicalTrials.gov标识符：NCT05182684。
