Key result
Disposable ECG leads show near-perfect agreement with reusable leads for measuring R-R intervals.
Why the study?
Single-use ECG leads have been developed to reduce healthcare-associated infection, but the validity and reliability of short-term HRV obtained from them needed comparison against standard reusable leads.
Do single-use disposable ECG leads provide valid and reliable short-term HRV measurements compared to standard reusable leads in healthy subjects?
Observational (n=30)
No
Do single-use disposable ECG leads provide valid and reliable short-term HRV measurements compared to standard reusable leads in healthy subjects?
Effect estimate: ICC 0.99 (95% CI 0.91-1.00)
Absolute Event Rate: 1016% vs 991%
Single-use disposable ECG leads can reliably replace reusable leads for short-term HRV monitoring, providing a valid tool that potentially reduces healthcare-associated infections.
May support disposable leads for short-term HRV in healthy volunteers; leaves open validation in patients and clinical settings.
Background and Aims Single‐use electrocardiography (ECG) leads have been developed to reduce healthcare‐associated infection. This study compared the validity and reliability of short‐term heart rate variability (HRV) obtained from single‐use disposable ECG leads. Methods Thirty healthy subjects (33 ± 10 years; 9 females) underwent 5‐min resting HRV assessments using disposable (single use) ECG cable and wire system (Kendall DL™ Cardinal Health) and a standard, reusable ECG leads (CardioExpress, Spacelabs Healthcare). Results Intraclass correlation coefficient (ICC) with 95% confidence interval (CI) between disposable and reusable ECG leads was for the time domain [R‐R interval (ms); 0.99 (0.91, 1.00)], the root mean square of successive normal R‐R interval differences (RMSSD) (ms); 0.91 (0.76, 0.96), the SD of normal‐to‐normal R‐R intervals (SDNN) (ms); 0.91 (0.68, 0.97) and frequency domain [low‐frequency (LF) normalized units (nu); 0.90 (0.79, 0.95), high frequency (HF) nu; 0.91 (0.80, 0.96), LF power (ms 2 ); 0.89 (0.62, 0.96), HF power (ms 2 ); 0.90 (0.72, 0.96)] variables. The mean difference and upper and lower limits of agreement between disposable and reusable leads for time‐ and frequency‐domain variables were acceptable. Analysis of repeated measures using disposable leads demonstrated excellent reproducibility (ICC 95% CI) for R‐R interval (ms); 0.93 (0.85, 0.97), RMSSD (ms); 0.93 (0.85, 0.97), SDNN (ms); 0.88 (0.75, 0.95), LF power (ms 2 ); 0.87 (0.72, 0.94), and HF power (ms 2 ); 0.88 (0.73, 0.94) with coefficient of variation ranging from 2.2% to 5% ( p > 0.37 for all variables). Conclusion Single‐use Kendall DL™ ECG leads demonstrate a valid and reproducible tool for the assessment of HRV.
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Okwose et al. (2022) conducted an observational in Healthy subjects (n=30). Single-use disposable ECG cable and wire system (Kendall DL) vs. Standard, reusable ECG leads (CardioExpress) was evaluated on Intraclass correlation coefficient (ICC) of R-R interval between disposable and reusable ECG leads (ICC 0.99, 95% CI 0.91-1.00). Single-use disposable ECG leads demonstrated excellent agreement with reusable leads for assessing R-R intervals (ICC 0.99) and other heart rate variability parameters.
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