Comparing non-invasive blood pressure measurements to invasive methods in critical care patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the validity of the Philips non-invasive blood pressure (NIBP) system by comparing its measurements to those obtained from an invasive radial arterial line in critical care settings. It will involve multiple centers and will assess various age groups, including neonates, children, and adults, to establish equivalence with the gold standard arterial line. The study will collect data from a predefined number of subjects and data points to ensure robust results.

Why it matters

Who can join: the full rules

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 it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting
• Oregon Health & Science University
  Portland, Oregon, United States Recruiting
• University Health Women's and Children's Hospital
  San Antonio, Texas, United States Recruiting
• Mayo Clinic Jacksonville
  Jacksonville, Florida, United States Completed
• University of Utah
  Salt Lake City, Utah, United States Terminated

Study contacts

• Study coordinator: Natalie Hernandez, MBA
• Email: natalie.hernandez@philips.com
• Phone: 210-517-4405

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.