758 - Feasibility of using the Boppli® device for continuous arterial blood pressure monitoring during neonatal transport.

Publication Number: 758.5064

Brooke A. Krbec, Floating Hospital for Children at Tufts Medical Center, West Roxbury, MA, United States; Thomas Roxlo, Pyrames, Cupertino, CA, United States; Celine Liong, PyrAmes Health, CUPERTINO, CA, United States; Faizah Wulandana, Tufts Medical Center, Somerville, MA, United States; Tejasvi Aryaputra, Floating Hospital for Children at Tufts Medical Center, Boston, MA, United States; Camille Hally, Tufts Medical Center, Cambridge, MA, United States; Joy Hilliard, Tufts Medical Center, West Yarmouth, MA, United States; Jennifer Killion, Tufts Childrens Hospital, Woburn, MA, United States; Phoebe White, Tufts University School of Medicine, Sommerville, MA, United States; Xina Quan, PyrAmes Inc., Cupertino, CA, United States

Background: Accurate blood pressure (BP) monitoring in the neonatal intensive care unit (NICU) is essential. Hemodynamic data provides vital information for the treatment of critically-ill neonates, but missed episodes of hypotension and hypertension using intermittent oscillometric cuff (NIBP) measurements and are associated with greater mortality. NIBP measurements are subject to inaccuracies in inpatient monitoring of neonates and on transport of critically ill patients. Near-continuous BP monitoring during the transport of critically ill pediatric patients has demonstrated improved outcomes.

Objective: To utilize the Boppli device for measurement of systolic (SBP), diastolic (DBP), and mean arterial pressure (MAP) during the transport of critically ill neonates compared to NIBP.

Design/Methods: This is a single-center clinical study utilizing the FDA-approved Boppli device for continuous arterial blood pressure monitoring. The device measures changes in capacitance of the radial or dorsalis pedis artery when placed on the wrist or foot. 13 neonatal patients requiring transport either to/from a level 3 NICU were enrolled by transport nurses and the Boppli device was placed and connected to a mobile device via Bluetooth to gather BP data. Accuracy of the device during transport was assessed by pairing Boppli to NIBP measurements where the mean absolute error (MAE) and standard deviation (SD) were calculated in a correlation analysis. The device then remained in place while inpatient for up to 72 hours.

Results: The 1-minute median of the differences between the Boppli and the NIBP were calculated for 11 participants. Boppli data was not collected for two participants. Two other subjects’ data had incorrect BP values that were affected by incorrect entry of age information. The SBP difference yielded MAE of 3.7, and SD of 5.4 mmHg (r=0.49). For DBP MAE was 2.2, SD of 5.9 mmHg (r=0.49). MAP had MAE of 5.2, SD of 4.9 mmHg (r=0.56). Figure 1 demonstrates the BP values inferred by the device compared to intermittent NIBP measurements for one subject.

Conclusion(s): Comparison of the NIBP to the Boppli revealed that it may be a suitable alternative to standard NIBP measurements for continuous hemodynamic monitoring during transport of critically ill neonatal patients. The majority of values were within the AAMI standards for device performance with a Bias of ± 5 mmHg and SD ± 8 mmHg utilizing current algorithms designed for stationary inpatient monitoring (Figure 2). Transport nurses reported that the device is easy to set-up and apply to the patient in a time-sensitive setting.

Figure 1
Boppli® BP values compared to intermittent NIBP measurements during transport and after transport for one subject. Comparison of transport period and post-transit period demonstrated closer accuracy of the device in transit for SBP, but less accurate results for DBP and MAP, although still within acceptable limits for FDA standards.

Figure 2
Bland Altman analysis for subject TUF-029 from Figure 1 demonstrating that mean bias and standard deviation for transport (black dots) and post-transit (gray dots) are within FDA targets (green lines) for accuracy at 5 mmHg for SBP, DBP and MAP. Red lines represent 2-sigma values.