NIBP Validation Study
ConditionCritical Illness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPhilips Clinical & Medical Affairs Global
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
The clinical study will be conducted in neonate, infant, pediatric, and adult patients admitted into the NICU/PICU/ICU/OR.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Philips IntelliVue X3 Patient Monitor
DeviceAll 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.
Treatment groups
189 Participants
are divided into 3 treatment groupsGroup A: Subject Group 11 intervention
Group B: Subject Group 21 intervention
Group C: Subject Group 31 intervention
Trial outcomes
Primary outcomes
1
Philips NIBP System Equivalence to Radial Arterial Line
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.
Time frame
Through study completion, approximately 1 yearSponsors and contacts
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Source ClinicalTrials.gov