Comparison of continuous non-invasive blood pressure measurement using Vitalstream™ to invasive Intraarterial pressure in pediatric surgery.

Abstract

Background: Accurate blood pressure monitoring is essential in many clinical scenarios for adults and children and, when continuous measurement is critical, necessitates the insertion of an arterial line. A novel continuous non-invasive arterial pressure monitoring device using a pulse contour algorithm (Pulse Decomposition Analysis), Vitalstream™, is approved by the United States Food and Drug Administration for use in adults. In this study the performance and accuracy of the device compared to intraarterial blood pressure monitoring were assessed in children ages 2-17 undergoing major surgeries. We report the results using comparison to aspects of the recently published ISO 81060-3:2022 standard for continuous automated blood pressure measurement.

Methods: 31 children ages 2-17 years scheduled for major surgery requiring invasive arterial blood pressure monitoring were consented to participate. Systolic, diastolic, and mean arterial blood pressure readings were obtained from both systems during at least thirty minutes of simultaneous monitoring during hemodynamically stable periods of the surgical procedure and statistically compared.

Results: The correlations of systolic and, diastolic, and mean arterial pressures were, respectively, 0.77, 0.68 and 0.7. The Bland-Altman comparisons yielded bias of -3.79 (9.74) mmHg, 1.72 (8.45) mmHg and 2.41 (8.75) mmHg respectively, for systolic, diastolic, and mean arterial pressures, (p < 0.001 for all comparisons). Concordances for systole, diastole and MAP were, respectively, 0.82, 0.85 and 0.83.

Conclusions: Most values fell within +/-20mmhg of the corresponding arterial line values. While this meets the basic requirement for such devices published by professional societies, clinicians will need to be aware of the potential variances and make clinical decisions accordingly. The Vitalstream™ may offer low risk, accurate continuous pressure monitoring in children ages 2-17.

Clinical trials: gov: NCT04817137 The trial was registered at clinicaltrials.gov (NCT048I7173).