NIBP Validation Study

Philips Clinical & Medical Affairs Global189 enrolled

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 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.

Study Type

OBSERVATIONAL

Enrollment

189

Conditions

Critical Illness

Interventions

Philips IntelliVue X3 Patient MonitorDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 patients shall be 1000 to 2000 g in weight * At least 3 patients shall be \> 2000 g in weight * At least 3 patients shall be ≥ 29 days and \< 1 year of age * At least 3 patients shall be ≥ 1 year and \< 3 years of age * The remaining patients may be from any of the above age or weight groups in order to complete the sample size * A patient can be in more than one category simultaneously * Subject Group 2: * At least 30% male, 30% female * Limb circumference distributed as specified in ISO81060-2:2018/Amd2:2024. * Subject Group 3: * At least 30% male, 30% female * Limb circumference distributed as specified in ISO81060- 2:2018/Amd-2:2024. * At least 10% SBP ≤ 100mmHg * At least 10% SBP ≥ 160mmHg * At least 10% DBP ≤ 70mmHg * At least 10% DBP ≥ 85mmHg 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 (\> 2 nd 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 (except for neonates with umbilical A-line) * If valid DBP reference measurements for lateral difference is \> 10 mmHg (except for neonates with umbilical A-line) * At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

Locations (5)

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

COMPLETED

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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.

Time frame: Through study completion, approximately 1 year

Central Contacts

Natalie Hernandez, MBA

CONTACT

210-517-4405 natalie.hernandez@philips.com

Shakun Karki

CONTACT

shakun.karki@philips.com

Data from ClinicalTrials.gov

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