Comparison of Twelve-Lead Electrocardiogram Using a Glove-Based Recording System With Standard Methodology

Abstract

We tested the clinically relevant diagnostic accuracy of a new electrocardiographic (ECG) recording system incorporating all 10 ECG electrodes in a single-size glove worn on the patient's left arm and placed on the chest. The PhysioGlove (PG) was designed to allow fast, reproducible, electrode placement with only minimal training. The American College of Cardiology/American Heart Association ECG recording guidelines and others have repeatedly highlighted the unacceptable progressive deterioration in ECG accuracy mainly resulting from a performer's lack of proficiency and diligence, leading to frequent electrode misplacement. We studied 428 consenting adult patients with a broad spectrum of anthropomorphic characteristics and ECG and cardiovascular pathologic entities. The chest girth was measured to ascertain the single-size PG clinical diagnostic accuracy in ≥90% of this patient population. For each patient, a PG and standard-cable electrocardiogram were consecutively recorded and interpreted by experienced electrocardiographers. The study included 3 phases: phase 1, run-in (n = 120); phase 2, comparative diagnostic accuracy (n = 208); and phase 3, randomized, blinded, diagnostic accuracy (n = 100). Of the entire study population (n = 428), 92% fit the chest girth range of 85 to 118 cm (34 to 47 in.), representing the reference standard clinical diagnostic PG chest girth range. The phase 2 PG diagnostic accuracy was 91.3% for entire chest girth range and 95.7% for the 89.4% of patients with a chest girth within the reference range. The mean PG diagnostic accuracy in phase 3 was 93% (95% confidence interval 89% to 95%). In conclusion, compared with standard-cable electrocardiograms, the PG demonstrated excellent diagnostic accuracy (93% to 95.7%) in ≥90% of a typical western adult patient population. The PG's ease of use and minimal training requirements offer a promising tool to markedly improve ECG clinical diagnostic accuracy in most adult western patients.