AbstractBackground
Accurate blood pressure monitoring is essential in many clinical scenarios for adults and children. A novel continuous non-invasive arterial pressure monitoring device using a pulse contour algorithm (pulse decomposition analysis), Vitalstream™, was recently cleared by the United States Food and Drug Administration for use in patients 18 years of age and older. Recently published ISO 81060–3:2022 standards for continuous automated blood pressure measurement were used to determine the accuracy (bias) and precision (repeatability) of the device in children ages 2–17 undergoing major surgeries compared to intraarterial blood pressure monitoring. Accuracy and precision are defined as acceptable if bias is within 6 mmHg and standard deviation within 10 mmHg.
Methods
A sample of 31 children ages 2–17 years scheduled for major surgery requiring invasive arterial blood pressure monitoring were consented to participate. Each patient was monitored with a radial arterial catheter and a Vitalstream™ monitor. Hemodynamic measures obtained from both systems during at least thirty minutes of simultaneous monitoring during the surgical procedure were analyzed using Pearson correlation coefficients as well as Bland-Altman and 4Q plot trend analyses.
Results
The correlations of systolic and diastolic arterial pressures were, respectively, 0.77 and 0.68. The Bland-Altman comparisons yielded bias (standard deviation) of 3.79 (9.74) mmHg and − 1.72 (8.45) mmHg for, respectively, systolic, and diastolic arterial pressures, (p < 0.001 for all comparisons). Concordances for systole and diastole were, respectively, 0.82 and 0.85.
Conclusions
In this study, continuous, beat by beat blood pressure measured using the non-invasive Vitalstream™ device correlated well with invasive arterial catheter measurements in the children. Most patients exhibited good agreement between methods, and the results were within established ISO limits for the validation of continuous automatic arterial pressure monitoring. The Vitalstream™ may offer low risk, accurate blood pressure monitoring in children ages 2–17.
The trial was registered at clinicaltrials.gov (NCT04817137)