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NCT Number: NCT05673408

NIBP 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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Jacksonville, Jacksonville, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Natalie Hernandez, MBA

CONTACT

[email protected]

210-517-4405

Shakun Karki

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Official study title

Non-Invasive Blood Pressure Validation Study

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Jan 6, 2023
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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