Non-Invasive Blood Pressure Validation Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- Philips Clinical & Medical Affairs Global
- Enrollment
- 189
- Locations
- 5
- Primary Endpoint
- Philips NIBP System Equivalence to Radial Arterial Line
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
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.
Investigators
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
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
Outcomes
Primary Outcomes
Philips NIBP System Equivalence to Radial Arterial Line
Time Frame: 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.