Actively Recruiting
NIBP Validation Study
Led by Philips Clinical & Medical Affairs Global · Updated on 2025-12-09
189
Participants Needed
5
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
NIBP Validation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 stratification criteria across study groups including age and weight for neonates, sex distribution, limb circumference, and blood pressure ranges as specified in ISO 81060-2:2018/Amd-2:2024
You will not qualify if you...
- 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 (> 2nd degree)
- Measurements taken in the lateral position
- Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with study endpoints
- 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)
- Subject does not qualify to participate at Principal Investigator's discretion for other reasons not mentioned above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Completed
2
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Not Yet Recruiting
3
Oregon Health & Science University
Portland, Oregon, United States, 97239
Not Yet Recruiting
4
University Health Women's and Children's Hospital
San Antonio, Texas, United States, 78229
Actively Recruiting
5
University of Utah
Salt Lake City, Utah, United States, 84112
Terminated
Research Team
N
Natalie Hernandez, MBA
CONTACT
S
Shakun Karki
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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