Abstract
Introduction: Accurate and continuous blood pressure (BP) monitoring in neonates is crucial in the intensive care unit. Invasive arterial lines (IALs), 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. 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) mm Hg for MAP, −0.8 (7.7) mm Hg for SBP, and 1.4 (4.7) mm Hg for DBP. Patients with elevated MAPs, Asian ethnicity, and lower extremity IALs were the subgroups with MAE >±5 mm Hg. Various subgroups had SDs >8 mm Hg attributed to low sample sizes. The device received high usability scores from clinicians and parents. No serious adverse events were reported. Conclusion: 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 2023, was well received by clinicians and parents, with a low-risk profile.
Plain Language Summary
This study tested a new device called the Boppli® that continuously and non-invasively monitors blood pressure in neonates without catheters or uncomfortable blood pressure cuffs. The Boppli works by tracking the pulse through the skin overlying an artery to calculate the patient’s blood pressure. We tested it on 79 babies (weighing less than 5kg) across five hospitals in the US and Canada, comparing its readings to those from arterial line readings. Our results showed that the Boppli gives reliable blood pressure measurements that matched closely with the gold standard method. The readings remained stable during the 72-hour testing period. Nurses and parents found the device easy to use and comfortable for the babies. We observed mild, temporary skin redness in 8% of babies, with no serious safety adverse events. The data presented suggest that the Boppli could provide a viable alternative to cuffs or invasive arterial lines, and contributed to FDA device clearance in September 2023. While our results are promising, more research is needed with larger groups of babies, especially those with very high or low blood pressure, to confirm the Boppli’s performance across all clinical situations.
