Human Factors Analysis of the CardioQuick Patch ®: A Novel Engineering Solution to the Problem of Electrode Misplacement during 12-lead Electrocardiogram Acquisition

Abstract Introduction The CardioQuick Patch ® (CQP) has been developed to assist operators in accurately positioning precordial electrodes during 12-lead electrocardiogram (ECG) acquisition. This study describes the CQP design and assesses the device in comparison to conventional electrode application. Methods 20 ECG technicians were recruited and a total of 60 ECG acquisitions were performed on the same patient model over four phases: (1) all participants applied single electrodes to the patient; (2) all participants were then re-trained on electrode placement and on how to use the CQP; (3) participants were randomly divided into two groups, the standard group applied single electrodes and the CQP group used the CQP; (4) after a one day interval, the same participants returned to carry out the same procedure on the same patient (measuring intra-practitioner variability). Accuracy was measured with reference to pre-marked correct locations using ultra violet ink. NASA-TLK was used to measure cognitive workload and the Systematic Usability Scale (SUS) was used to quantify the usability of the CQP. Results There was a large difference between the minimum time taken to complete each approach (CQP = 38.58 s vs. 65.96 s). The standard group exhibited significant levels of electrode placement error (V1 = 25.35 mm ± 29.33, V2 = 18.1 mm ± 24.49, V3 = 38.65 mm ± 15.57, V4 = 37.73 mm ± 12.14, V5 = 35.75 mm ± 15.61, V6 = 44.15 mm ± 14.32). The CQP group had statistically greater accuracy when placing five of the six electrodes (V1 = 6.68 mm ± 8.53 [ p < 0.001], V2 = 8.8 mm ± 9.64 [ p = 0.122], V3 = 6.83 mm ± 8.99 [ p < 0.001], V4 = 14.90 mm ± 11.76 [ p < 0.001], V5 = 8.63 mm ± 10.70 [ p < 0.001], V6 = 18.13 mm ± 14.37 [ p < 0.001]). There was less intra-practitioner variability when using the CQP on the same patient model. NASA TLX revealed that the CQP did increase the cognitive workload (CQP Group = 16.51% ± 8.11 vs. 12.22% ± 8.07 [ p = 0.251]). The CQP also achieved a high SUS score of 91 ± 7.28. Conclusion The CQP significantly improved the reproducibility and accuracy of placing precordial electrodes V1, V3-V6 with little additional cognitive effort, and with a high degree of usability.