Philips Clinical & Medical Affairs Global
The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial for Subject Group 2 and 3, and radial or umbilical arterial line for neonates (A-line) in critical care patients.
A multi-center, multi-phase, prospective, self-controlled, observational study. * Phase I - A pilot phase designed for feasibility and the potential for algorithm development (enhancement). * Phase II - Pivotal Phase: At the completion of Phase I -and finalization of the algorithm (if applicable), Phase II is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard radial or umbilical (neonates) arterial line.
Inclusion Criteria: * Patient admitted into the NICU, PICU, ICU, or OR (operating room) * Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent * Indication for NIBP cuff * Indication for radial arterial line for Subject Group 2 and Subject Group 3, and radial or umbilical arterial line for Subject Group 1 * Meet the following stratification criteria across the study: Stratification (per the ISO 81060-2:2018/Amd-2:2024): * Subject Group 1: * At least 3 patients shall be \<1000 g in weight * At least 3 patien…
All subjects enrolled in this study will receive one Philips non-invasive blood pressure cuff. This cuff will be connected via compatible hose to the Philips IntelliVue X3 monitor hosting the released or investigational NIBP algorithm. The invasive blood pressure from the radial arterial line will also be connected to the Philips IntelliVue X3 monitor. The Philips IntelliVue X3 monitor will in turn be connected to a laptop for data collection.
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