Clinical trial NCT05673408: NIBP Validation Study
Official title: Non-Invasive Blood Pressure Validation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2023-01-06
Enrollment: 189
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The clinical study will be conducted in neonate, infant, pediatric, and adult patients admitted into the NICU/PICU/ICU/OR.

Brief summary: 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 arterial line (A-line) in critical care patients.

Detailed description: This is a multicenter, multi-phase, prospective, non-randomized, self-controlled, observational study to evaluate the validity of Philips non-invasive blood pressure technology.

This study is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard arterial line.

Main Phase will be considered complete when the number of pre-defined subjects and data points are achieved per subject group.

* Subject Group 1: Neonates, Infant, Children \<3 years of age Minimum of 24 subjects and 180 data points
* Subject Group 2: children 3-12 years of age Minimum of 41 subjects and 205 data points
* Subject Group 3: Adolescent/Adult \>12 years of age Minimum of 124 subjects and 620 data points

Eligibility criteria: Inclusion Criteria:

* Patient admitted into the Neonatal Intensive Care Unit (NICU), Pediatric Intensive Care Unit (PICU), Intensive Care Unit (ICU), or Operating Room (OR)
* 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

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 (\> 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 the study endpoint(s)
* If valid SBP reference measurements for lateral difference is \> 15 mmHg
* If valid DBP reference measurements for lateral difference is \> 10 mmHg
* At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above

Primary outcomes:
measure: Philips NIBP System Equivalence to Radial Arterial Line
timeFrame: Through study completion, approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: