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Recruiting NCT05673408

NIBP Validation Study

— Observational Critical Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Philips IntelliVue X3 Patient Monitor.
Who it may be relevant to
Registry conditions: Critical Illness. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-Invasive Blood Pressure Validation Study

Overview

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.

Detailed description

A multi-center, multi-phase, prospective, self-controlled, observational study.

* Phase I - A pilot phase designed for feasibility and the potential for algorithm development (enhancement). * Phase II - Pivotal Phase: At the completion of Phase I -and finalization of the algorithm (if applicable), Phase II is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard radial or umbilical (neonates) arterial line.

Interventions

  • Device 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 measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 5 centers
  • Mayo Clinic Jacksonville — Jacksonville
  • Wake Forest University Health Sciences — Winston-Salem
  • Oregon Health & Science University — Portland
  • University Health Women's and Children's Hospital — San Antonio
  • University of Utah — Salt Lake City

Identifiers

NCT: NCT05673408 · CC_MA_NIBPValidation_2022_1151

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗