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Philips NIBP Validation Study for Critical Illness

This study is comparing a Philips non-invasive blood pressure (NIBP) system, which includes a special cuff and a portable patient monitor (Philips IntelliVue X3 Patient Monitor), to traditional invasive blood pressure measurements (radial or umbilical arterial line) in patients with critical illness. The goal is to see if the Philips NIBP system gives similar blood pressure readings to the invasive method. You might be able to join if you are an adult (18 or older) or a minor whose parent/guardian can consent, and you are in a critical care unit (NICU, PICU, ICU, or OR) and need both an NIBP cuff and an arterial line. The study aims to determine if the Philips NIBP system is equivalent to the invasive arterial line method.

Study design
This is an observational study that will enroll 189 participants. It is a multi-center, multi-phase study that compares blood pressure measurements within the same patient.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure measurements will be compared throughout the study, which is expected to last approximately 1 year.

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NCT05673408

NIBP Validation Study

Recruiting
Not specifiedAll AgesObservational
Philips Clinical & Medical Affairs Global
~189 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Philips IntelliVue X3 Patient Monitor

At a glance

Recruiting sites
3 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Philips NIBP System Equivalence to Radial Arterial Line
Measured over Through study completion, approximately 1 year

Conditions

Critical Illness

Explore related trials

Critical Illness

Where it's being run

5 sites across 5 states
Florida1
North Carolina1
Oregon1
Texas1
Utah1

Who to contact

Natalie Hernandez, MBA
[email protected]
210-517-4405
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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

What this trial measures

  • Philips NIBP System Equivalence to Radial Arterial LineThrough 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.