NIBP Validation Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Phase I - Roll-in Phase is a pilot designed for feasibility and the potential for algorithm development (enhancement).
Phase II - Pivotal Phase: At the completion of Phase I - Roll in Phase 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 arterial line.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Subject Group 1 Neonates, Infant, Children <3 years of age |
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.
|
| Subject Group 2 Children 3-12 years of age |
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.
|
| Subject Group 3 Adolescent/Adult >12 years of age |
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient admitted into the NICU, PICU, or ICU
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Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent
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Indication for NIBP cuff
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Indication for radial arterial line
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Meet the following stratification criteria across the study:
Stratification:
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Subject Group 1:
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At least 3 patients shall be <1000 g in weight
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At least 3 patients shall be 1000 to 2000 g in weight
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At least 3 patients shall be > 2000 g in weight
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At least 3 patients shall be ≥ 29 days and < 1 year of age
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At least 3 patients shall be ≥ 1 year and < 3 years of age
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The remaining patients may be from any of the above age or weight groups in order to complete the sample size
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A patient can be in more than one category simultaneously
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Subject Group 2 and 3:
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At least 30% male, 30% female
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At least 1/10 of total adolescent/adult ≥ 3 years of age needs to be tested with each cuff size (5 cuff sizes total)
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at least 40% of the subjects shall have a limb circumference that lies within the upper half of the specified range of use of the cuff; and
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at least 40% shall have a limb circumference within the lower half of the specified range of use
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Subject Group 3:
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At least 10% SBP ≤ 100mmHg
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At least 10% SBP ≥ 160mmHg
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At least 10% DBP ≤ 70mmHg
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At least 10% DBP ≥ 85mmHg
Exclusion Criteria:
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Inability to place the study device appropriately due to patient's anatomy or condition
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Known pregnancy or lactating women (self-report)
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Patients treated with an intra-aortic balloon pump
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Aortic and mitral regurgitation (> 2nd degree)
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Measurements taken in the lateral position
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Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
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If valid SBP reference measurements for lateral difference is > 15 mmHg
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If valid DBP reference measurements for lateral difference is > 10 mmHg
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At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Philips Clinical & Medical Affairs Global
Investigators
- Study Director: Amir Abdolahi, Philips Healthcare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC_MA_NIBPValidation_2022_1151