NIBP Validation Study

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 arterial line (A-line) in critical care patients.

Inclusion Criteria:Patient admitted into the NICU, PICU, or ICUAdult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assentIndication for NIBP cuffIndication for radial arterial lineMeet the following stratification criteria across the study:Stratification:Subject Group 1:At least 3 patients shall be <1000 g in weightAt least 3 patients shall be 1000 to 2000 g in weightAt least 3 patients shall be > 2000 g in weightAt least 3 patients shall be ≥ 29 days and < 1 year of ageAt least 3 patients shall be ≥ 1 year and < 3 years of ageThe remaining patients may be from any of the above age or weight groups in order to complete the sample sizeA patient can be in more than one category simultaneouslySubject Group 2 and 3:At least 30% male, 30% femaleAt least 1/10 of total adolescent/adult ≥ 3 years of age needs to be tested with each cuff size (5 cuff sizes total)at least 40% of the subjects shall have a limb circumference that lies within the upper half of the specified range of use of the cuff; andat least 40% shall have a limb circumference within the lower half of the specified range of useSubject Group 3:At least 10% SBP ≤ 100mmHgAt least 10% SBP ≥ 160mmHgAt least 10% DBP ≤ 70mmHgAt least 10% DBP ≥ 85mmHgExclusion Criteria:Inability to place the study device appropriately due to patient's anatomy or conditionKnown pregnancy or lactating women (self-report)Patients treated with an intra-aortic balloon pumpAortic and mitral regurgitation (> 2nd degree)Measurements taken in the lateral positionCurrently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)If valid SBP reference measurements for lateral difference is > 15 mmHgIf valid DBP reference measurements for lateral difference is > 10 mmHgAt the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above