NIBP Validation Study
Recruiting now
Conditions studied: Critical Illness
In brief
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.
Key facts
- Study ID
- NCT05673408
- Run by
- Philips Clinical & Medical Affairs Global
- People needed
- 189
- Starts
- 2023-06-23
- Expected to finish
- 2027-03-31
- Last updated by the study team
- 2026-05-26
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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:
- 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
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
Where it is running
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- University Health Women's and Children's Hospital — San Antonio, Texas, United States (enrolling)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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