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. 2023 Apr 2;23(7):3690.
doi: 10.3390/s23073690.

Clinical Study of Continuous Non-Invasive Blood Pressure Monitoring in Neonates

Affiliations

Clinical Study of Continuous Non-Invasive Blood Pressure Monitoring in Neonates

Anoop Rao et al. Sensors (Basel). .

Abstract

The continuous monitoring of arterial blood pressure (BP) is vital for assessing and treating cardiovascular instability in a sick infant. Currently, invasive catheters are inserted into an artery to monitor critically-ill infants. Catheterization requires skill, is time consuming, prone to complications, and often painful. Herein, we report on the feasibility and accuracy of a non-invasive, wearable device that is easy to place and operate and continuously monitors BP without the need for external calibration. The device uses capacitive sensors to acquire pulse waveform measurements from the wrist and/or foot of preterm and term infants. Systolic, diastolic, and mean arterial pressures are inferred from the recorded pulse waveform data using algorithms trained using artificial neural network (ANN) techniques. The sensor-derived, continuous, non-invasive BP data were compared with corresponding invasive arterial line (IAL) data from 81 infants with a wide variety of pathologies to conclude that inferred BP values meet FDA-level accuracy requirements for these critically ill, yet normotensive term and preterm infants.

Keywords: NICU; cNIBP; hypertension; hypotension; neonate; non-invasive blood pressure monitoring.

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Conflict of interest statement

Y.W., E.B., T.R., J.L., A.W., A.M., W.L., X.Q. and K.D. are/were employees/contractors of PyrAmes. No conflict are reported for A.R., F.E.-A., E.H., A.J., A.V., C.R., A.H., W.R., R.B.G. and N.S.

Figures

Figure 1
Figure 1
(a) Boppli sensor schematic: illustration of the sensor and wearable, continuous, non-invasive BP device for neonates (cross-sectional at the top; aerial view at the bottom); (b) Boppli sensor placement around the foot of an infant.
Figure 2
Figure 2
Overview of the working of the sensor and steps to infer blood pressure.
Figure 3
Figure 3
Bland–Altman plots for SBP, DBP, and MAP: (a) values averaged over each individual for 81 test patients; and (b) all data values without averaging. Bland–Altman plots represent a scatter plot of average versus difference of BP readings constructed for SBP, DBP, and MAP. Points are color coded by patient weight. Red dotted lines indicate 2 * SD of the calculated values. Green dotted lines indicate targets based on FDA guidelines for accuracy of MAE ≤ 5 mmHg and 2 * SD ≤ 2 * 8 mmHg. The figures were generated using JMP software version 16.2.0.
Figure 4
Figure 4
Predicted BP values vs. ground truth values. The blue line represents an unconstrained linear fit to the data. The green line is a linear fit constrained by a zero-intercept. The grey line is the identity (ID) fit where the predicted values equal the ground truth values. The figures were generated using JMP software version 16.2.0.
Figure 5
Figure 5
Effect of gestational age (GA) on efficacy. Groups categorized by prematurity are compared through mean diamonds (green) and Tukey–Kramer circles (black). EPT (<28 wks GA), MPT (28–37 wks GA), FT (≥38 wks GA). Overlap between diamonds and circles indicates there is no significant difference between groups. Mean diamonds are contained within the FDA guidelines for accuracy (dotted green lines). Targets for 95% confidence levels are indicated with dashed green lines. Points are color-coded by patient weight.
Figure 6
Figure 6
Effect of sex on efficacy. Female and male patient subsets are compared through mean diamonds (green) and Tukey–Kramer circles (black). Minimal overlap between diamonds and circles indicates there is a significant difference between the two groups. Mean diamonds are contained within the FDA guidelines for accuracy (dotted green lines). Targets for 95% confidence levels are indicated with dashed green lines. Points are color-coded by patient weight.
Figure 6
Figure 6
Effect of sex on efficacy. Female and male patient subsets are compared through mean diamonds (green) and Tukey–Kramer circles (black). Minimal overlap between diamonds and circles indicates there is a significant difference between the two groups. Mean diamonds are contained within the FDA guidelines for accuracy (dotted green lines). Targets for 95% confidence levels are indicated with dashed green lines. Points are color-coded by patient weight.

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