Validation of 12-Lead Smartphone-Based Spandan Ultra 12L Electrocardiogram Durations and Amplitudes Analysis as Compared to the Standard 12-Lead Electrocardiogram

Background
Electrocardiography (ECG) is a valuable tool for diagnosing cardiac disorders, with a 12-lead ECG being the gold standard. However, the traditional 12-lead ECG machine is hospital-based, which restricts access. The Smartphone-based 12-Lead ECG (Spandan Ultra 12L ECG) is a portable, simultaneous 12-lead ECG device designed for real-time cardiac monitoring. This study compares its accuracy with a Standard 12-lead ECG system (Philips PageWriter ECG).
Objective
To evaluate the accuracy and reliability of the Smartphone-based 12-Lead ECG device in measuring ECG interval, amplitude, and duration measurements as compared to the Standard 12-lead ECG.
Methods
A prospective, single-blinded, cross-sectional study was conducted in a hospital ECG room in Dehradun, India. 405 participants aged ≥ 20 years in ECG recordings using the both the ECG machine. After applying the exclusion criteria, 75 participants were excluded, and 330 participants' ECG recordings were analyzed. Statistical analyses included paired t-tests to compare significant differences, Pearson correlation coefficients (PCC) to assess linear association, and Bland-Altman (BA) analysis to evaluate the agreement between the two devices.
Results
Twelve-lead Standard (n=330) and Smartphone-based 12-Lead (n=330) ECG waveforms from 330 participants (mean age 52.14 years); 169 (51.21%) males were analyzed. No statistically significant differences were found between both the ECGs for all measured parameters, with p-values ranging from 0.090 for P-wave duration to 0.965 for Q-wave amplitude. PCC showed high linear correlation between the both the ECGs across ECG intervals (0.818-0.938), amplitudes (>0.92), and durations (0.700-0.944). BA analysis confirmed minimal bias, with limits of agreement (LOA) within clinically acceptable ranges.
Conclusion
The Smartphone-based 12-Lead ECG device showed high accuracy and reliability in the evaluation of ECG parameters, as compared to the Standard 12-lead ECG system. Its portability, smartphone compatibility, and ease of use make it a promising diagnostic tool for regular clinical applications and timely ECG assessment.