Overview
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.
Description
This is a multicenter, multi-phase, prospective, non-randomized, self-controlled, observational study to evaluate the validity of Philips non-invasive blood pressure technology.
This study is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard arterial line.
Main Phase will be considered complete when the number of pre-defined subjects and data points are achieved per subject group.
- Subject Group 1: Neonates, Infant, Children <3 years of age Minimum of 24 subjects and 180 data points
- Subject Group 2: children 3-12 years of age Minimum of 41 subjects and 205 data points
- Subject Group 3: Adolescent/Adult >12 years of age Minimum of 124 subjects and 620 data points
Eligibility
Inclusion Criteria:
- Patient admitted into the Neonatal Intensive Care Unit (NICU), Pediatric Intensive Care Unit (PICU), or Intensive Care Unit (ICU)
- 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
Exclusion Criteria:
- Inability to place the study device appropriately due to patient's anatomy or condition
- Known pregnancy or lactating women (self-report)
- Patients treated with an intra-aortic balloon pump
- Aortic and mitral regurgitation (> 2nd degree)
- Measurements taken in the lateral position
- Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
- Currently receiving vasopressors during data collection
- If valid SBP reference measurements for lateral difference is > 15 mmHg
- If valid DBP reference measurements for lateral difference is > 10 mmHg
- At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above