This is a prospective, multi-center clinical study to validate the effectiveness of the Boppli Blood Pressure Monitor as compared to an invasive arterial reference. This study will evaluate the accuracy and precision of the Boppli system for continuous blood pressure monitoring by comparing SBP, DBP, and MAP against the reference methodology in pediatric and neonatal populations.
Primary Effectiveness Endpoint: Mean and standard deviation of the difference of the paired measurements between the device and arterial line reference for systolic, diastolic and mean pressures treated separately.
Safety endpoint: Device related adverse events
To assess the accuracy of the test device, a mean average difference of +/- 5 mmHg with a standard deviation of 8 mmHg of difference between the test device and the intra-arterial reference method will be considered as the upper limits of clinically acceptable disagreement. These parameters are in accordance with ISO 81060-2 and ANSI/AAMI SP10 for neonatal/infant populations using an intra-arterial method as the reference standard.
In addition to the test of accuracy, the stability test will be used to assess the accuracy over the duration of use of the device.
The change test will be used to demonstrate that the Boppli device will measure clinically relevant changes in BP measurements.