Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.

Abstract

Background: Accurate and continuous blood pressure (BP) monitoring in neonates is crucial in the Intensive Care Unit. Invasive arterial lines, oscillometric cuffs, and current noninvasive continuous BP monitoring devices have significant limitations. The Boppli® device is a novel, continuous, noninvasive BP device that requires no calibration, designed for neonates. Aim & Methods: This prospective, multicenter study evaluated the performance, usability, and safety of the Boppli device in neonates <5 kg. We compared Mean Arterial Pressure (MAP), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measurements from the Boppli with IAL reference values by calculating average values of Mean Average Error (MAE) and Standard Deviation (SD) for each patient, then averaging those means. Safety and usability were evaluated by analysis of adverse events and survey data, respectively.

Results: The Boppli device demonstrated good performance, meeting the FDA requirements of MAE and SD of the entire cohort: MAE (SD) 0.7 (5.3) mmHg for MAP, -0.8 (7.7) mmHg for SBP, and 1.4 (4.7) mmHg for DBP. Patients with elevated MAPs, Asian ethnicity, and lower extremity IALs were the subgroups with MAE >±5 mmHg. Various subgroups had standard deviations >8 mmHg attributed to low sample sizes. The device received high usability scores from clinicians and parents. No serious adverse events were reported.

Conclusions: The Boppli device is a promising alternative for continuous noninvasive BP monitoring in neonates, offering good accuracy and usability. The device, which received 510(k) clearance in September of 2023, was well-received by clinicians and parents, with a low risk profile.