NIBP Validation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Non-Invasive Blood Pressure Validation Study

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Philips IntelliVue X3 Patient Monitor


Participation Criteria
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Eligibility Criteria
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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) 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject Group 1<br>Neonates, Infant, Children <3 years of age | Device: Philips IntelliVue X3 Patient Monitor<br>* 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.<br>|
| Subject Group 2<br>Children 3-12 years of age | Device: Philips IntelliVue X3 Patient Monitor<br>* 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.<br>|
| Subject Group 3<br>Adolescent/Adult >12 years of age | Device: Philips IntelliVue X3 Patient Monitor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Philips NIBP System Equivalence to Radial Arterial Line | The primary endpoint is the accuracy and precision of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) measured by the Philips NIBP system (including NIBP cuff and portable patient monitor) in comparison to radial arterial line. | Through study completion, approximately 1 year |