Recruiting

Observational Study

Sponsor:

Philips Clinical & Medical Affairs Global

Code:

NCT05673408

Conditions

Critical Illness

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Philips IntelliVue X3 Patient Monitor

Study Details

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 for Subject Group 2 and 3, and radial or umbilical arterial line for neonates (A-line) in critical care patients.

Conditions

Critical Illness

Study ID

NCT05673408

Start date

Jun 23, 2023

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

189 participants

Anticipated

Interventions and Outcome Measures

Arms

Subject Group 1

Neonates, Infant, Children <3 years of age

Subject Group 2

Children 3-12 years of age

Subject Group 3

Adolescent/Adult >12 years of age

Interventions

Philips IntelliVue X3 Patient Monitor

All subjects enrolled in this study will receive one Philips non-invasive blood pressure cuff. This cuff will be connected via compatible hose to the Philips IntelliVue X3 monitor hosting the released or investigational NIBP algorithm. The invasive blood pressure from the radial arterial line will also be connected to the Philips IntelliVue X3 monitor. The Philips IntelliVue X3 monitor will in turn be connected to a laptop for data collection.

Primary outcome measure

  • Philips NIBP System Equivalence to Radial Arterial Line [ Time Frame: Through study completion, approximately 1 year ]

Central Contacts and Locations

Central contacts

Natalie Hernandez, MBA

210-517-4405natalie.hernandez@philips.com

Shakun Karki

shakun.karki@philips.com

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator:

Ashish Khanna, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Ross Martini, MD

University Health Women's and Children's Hospital

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Diana G Anzueto

2105675254anzuetod@uthscsa.edu

Principal Investigator:

Amy Quinn, MD

More Information

Sponsor

Philips Clinical & Medical Affairs Global

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • NIBP Validation
  • Non-Invasive Blood Pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philips Clinical & Medical Affairs Global on 2026-05-26.