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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject Group 1 | Neonates, Infant, Children <3 years of age |
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| Subject Group 2 | Children 3-12 years of age |
| |
| Subject Group 3 | Adolescent/Adult >12 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips IntelliVue X3 Patient Monitor | Device | 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. |
| 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 |
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Inclusion Criteria:
Stratification (per the ISO 81060-2:2018/Amd-2:2024):
Subject Group 1:
Subject Group 2:
Subject Group 3:
Exclusion Criteria:
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The clinical study will be conducted in neonate, infant, pediatric, and adult patients admitted into the NICU/PICU/ICU/OR.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Hernandez, MBA | Contact | 210-517-4405 | natalie.hernandez@philips.com | |
| Shakun Karki | Contact | shakun.karki@philips.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Jacksonville | Completed | Jacksonville | Florida | 32224 | United States | |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Wake Forest University Health Sciences |
| Recruiting |
| Winston-Salem |
| North Carolina |
| 27157 |
| United States |
|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
|
| University Health Women's and Children's Hospital | Recruiting | San Antonio | Texas | 78229 | United States |
|
| University of Utah | Terminated | Salt Lake City | Utah | 84112 | United States |