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

Non-Invasive Blood Pressure Validation Study

This study is testing a new non-invasive blood pressure device to see if it gives accurate readings compared to the standard invasive method in critical care patients of all ages.

Quick facts

• Study type: Observational
• Enrollment: 189 (estimated)
• Sex: All
• Sponsor: Philips Clinical & Medical Affairs Global (Industry-sponsored)
• Locations: 5 sites (Jacksonville, Florida and 4 other locations)
• Trial ID: NCT05673408 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients admitted to intensive care units or operating rooms who require blood pressure monitoring and have an indication for both NIBP cuff and radial arterial line.

Not a fit: Patients who may not benefit include those with anatomical conditions preventing proper placement of the study device or those with specific cardiac conditions that could interfere with accurate measurements.

Why it matters

Potential benefit: If successful, this study could provide a reliable non-invasive method for monitoring blood pressure in critical care patients, potentially improving patient comfort and safety.

How similar studies have performed: Other studies have shown success in validating non-invasive blood pressure monitoring technologies, suggesting that this approach is promising and not entirely novel.

Eligibility criteria

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 this trial is running

Jacksonville, Florida and 4 other locations

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

Study contacts

• Study coordinator: Natalie Hernandez, MBA

Conditions Critical Illness; NIBP Validation; Non-Invasive Blood Pressure