NIBP Validation Study

NCT05673408 | Recruiting FDA Device

• 1 other identifier: CC_MA_NIBPValidation_2022_1151
• Study Type: observational
• Target: 189
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Critical Illness

Keywords

NIBP Validation; Non-Invasive Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Subject Group 1

Neonates, Infant, Children \<3 years of age

Device: Philips IntelliVue X3 Patient Monitor

Subject Group 2

Children 3-12 years of age

Device: Philips IntelliVue X3 Patient Monitor

Subject Group 3

Adolescent/Adult \>12 years of age

Device: Philips IntelliVue X3 Patient Monitor

Interventions

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.

Subject Group 1; Subject Group 2; Subject Group 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The clinical study will be conducted in neonate, infant, pediatric, and adult patients admitted into the NICU/PICU/ICU/OR.

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (5)

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

COMPLETED

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

NOT YET RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

University Health Women's and Children's Hospital

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

TERMINATED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Natalie Hernandez, MBA

CONTACT

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

Shakun Karki

CONTACT

shakun.karki@philips.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 6, 2023
• Study Start: June 23, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

US (5)