NIBP Validation Study

May 21, 2026 updated by: Philips Clinical & Medical Affairs Global

Non-Invasive Blood Pressure Validation Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (Estimated)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Completed
        • Mayo Clinic Jacksonville
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Principal Investigator:
          • Ashish Khanna, MD
        • Contact:
          • Lynnette Harris, BSN,RN,CCRC
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Sarah Feller
        • Principal Investigator:
          • Ross Martini, MD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University Health Women's and Children's Hospital
        • Principal Investigator:
          • Amy Quinn, MD
        • Sub-Investigator:
          • Megan Foster, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Terminated
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subject Group 1
Neonates, Infant, Children <3 years of age
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.
Subject Group 2
Children 3-12 years of age
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.
Subject Group 3
Adolescent/Adult >12 years of age
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Philips NIBP System Equivalence to Radial Arterial Line
Time Frame: Through study completion, approximately 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Investigators

  • Study Director: Amir Abdolahi, Philips Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2023

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 3, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC_MA_NIBPValidation_2022_1151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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