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RECRUITING

NCT05673408

NIBP Validation Study

Sponsor: Philips Clinical & Medical Affairs Global

View on ClinicalTrials.gov

Summary

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.

Official title: Non-Invasive Blood Pressure Validation Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

189

Start Date

2023-06-23

Completion Date

2026-12-31

Last Updated

2025-12-09

Healthy Volunteers

Conditions

Critical Illness

Interventions

DEVICE

Philips IntelliVue X3 Patient Monitor

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.

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

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

University Health Women's and Children's Hospital

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States