JMIR Publications

ABSTRACT

Background:

In the emergency department, 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.

Objective:

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.

Methods:

Adult patients who visited the emergency room with chest pain but were not in shock were randomly assigned to one of the two groups: to the SP-ECG group or to the C-ECG group. The final analysis included 33 of the 36 patients recruited. The primary outcome was the comparison of the time taken by the two groups to record the ECG. The average ages of the participants in the SP-ECG and C-ECG groups were 63.7 and 58.1 years, respectively.

Results:

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 chest pain patients 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%, respectively, at the second follow-up, respectively(p=71).

Conclusions:

Continuous ECG monitoring with minimal interference from other examinations is feasible and essential in complex emergency department situations. However, the precision of SP-ECG has not yet been proven. Nevertheless, the application of SP-ECG is expected to improve overcrowding and human resource shortages in emergency departments; however, more research is needed. Clinical Trial: ClinicalTrials.gov registry NCT04114760