NCT05673408 · Philips Clinical & Medical Affairs Global
NIBP Validation Study
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Jacksonville, Florida
- Winston-Salem, North Carolina
- Portland, Oregon
- San Antonio, Texas
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2026 · Source of record for eligibility and locations