NIBP Validation Study

Recruiting

• Conditions: Critical Illness
• Interventions: Device: Philips IntelliVue X3 Patient Monitor

• Registration Number: NCT05673408
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-06
• Study Start: 2023-06-23
• Status Verified: 2024-07
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject Group 1	Philips IntelliVue X3 Patient Monitor	Neonates, Infant, Children \<3 years of age
Subject Group 2	Philips IntelliVue X3 Patient Monitor	Children 3-12 years of age
Subject Group 3	Philips IntelliVue X3 Patient Monitor	Adolescent/Adult \>12 years of age

Primary Outcome Measures

Name	Time	Method
Philips NIBP System Equivalence to Radial Arterial Line	Through study completion, approximately 1 year	The primary endpoint is the accuracy and precision of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) measured by the Philips NIBP system (including NIBP cuff and portable patient monitor) in comparison to radial arterial line.

Trial Locations

Locations (5)

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States