No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Any
Study type
Observational
Participants needed
189 (estimated)
Sponsor
Philips Clinical & Medical Affairs Global · Industry
Who this trial is looking for
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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.
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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…
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
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