Blood Pressure Monitoring for Critical Illness Patients
NIBP Validation Study
Recruiting
Observational Study
Critical Illness
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.
Ready to participate?
Review the details below, then apply to join this clinical trial.
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
This trial is looking for patients in critical care settings to help compare a new blood pressure monitoring device with standard methods. Participants will have their blood pressure measured while receiving critical care treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am in a Neonatal Intensive Care Unit (NICU), Pediatric Intensive Care Unit (PICU), Intensive Care Unit (ICU), or Operating Room (OR).
I am 18 years or older, or a parent/legal guardian of a minor.
I need a non-invasive blood pressure cuff.
I require a radial arterial line or umbilical arterial line.
You may not be able to join if
I cannot have the study device placed due to my anatomy or condition.
I am pregnant or currently breastfeeding.
I am currently receiving treatment with an intra-aortic balloon pump.
I have a severe heart condition like aortic or mitral regurgitation.
My blood pressure measurements show a significant lateral difference.
I am participating in another clinical trial that affects this study.
The study doctor decides I cannot participate for any other reasons.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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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