NIBP Validation Study

Philips

Status

Enrolling

Conditions

Critical Illness

Treatments

Device: Philips IntelliVue X3 Patient Monitor

Study type

Observational

Funder types

Industry

Identifiers

NCT05673408

CC_MA_NIBPValidation_2022_1151

Details and patient eligibility

About

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.

Full 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.

Enrollment

189 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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