Abstract
Background
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.
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 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.
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 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).
Conclusions
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.
Trial Registration
ClinicalTrials.gov NCT04114760; https://clinicaltrials.gov/ct2/show/NCT04114760