Critical IllnessNCT05673408
NIBP Validation Study
An observational study of Critical Illness, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- Philips IntelliVue X3 Patient Monitor
- Type of treatment
- Medical device
- How many people
- 189 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Jun 2023to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The clinical study will be conducted in neonate, infant, pediatric, and adult patients admitted into the NICU/PICU/ICU/OR.
Who may be able to join
- 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):
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shakun Karki contact
5 sites in 1 country
United States5 sites, 3 recruiting
- Completed
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Sarah Feller
Ross Martini, MD
- Terminated
University of Utah
Salt Lake City, Utah, 84112
- Recruiting
University Health Women's and Children's Hospital
San Antonio, Texas, 78229
Diana G Anzueto, 2105675254, anzuetod@uthscsa.edu
Amy Quinn, MD
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Lynnette Harris, BSN,RN,CCRC
Ashish Khanna, MD
About this study
Official title: Non-Invasive Blood Pressure Validation Study
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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Philips IntelliVue X3 Patient Monitor
- Keywords
- NIBP Validation, Non-Invasive Blood Pressure
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips IntelliVue X3 Patient MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subject Group 1 | Neonates, Infant, Children <3 years of age Receives: Device: Philips IntelliVue X3 Patient Monitor | |
| Subject Group 2 | Children 3-12 years of age Receives: Device: Philips IntelliVue X3 Patient Monitor | |
| Subject Group 3 | Adolescent/Adult >12 years of age Receives: Device: Philips IntelliVue X3 Patient Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start23 Jun 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673408
- Sponsor's protocol ID
- CC_MA_NIBPValidation_2022_1151
- Status last verified
- May 2026
- First submitted
- 3 Jan 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Blood Pressure Validation Study
- ClinicalTrials.gov ID
- NCT05673408
- Acronym / sponsor ID
- CC_MA_NIBPValidation_2022_1151
- Conditions
- Critical Illness
- Keywords
- NIBP Validation, Non-Invasive Blood Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subject Group 1 | – | Device: Philips IntelliVue X3 Patient MonitorNeonates, Infant, Children <3 years of age |
| Subject Group 2 | – | Device: Philips IntelliVue X3 Patient MonitorChildren 3-12 years of age |
| Subject Group 3 | – | Device: Philips IntelliVue X3 Patient MonitorAdolescent/Adult >12 years of age |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The clinical study will be conducted in neonate, infant, pediatric, and adult patients admitted into the NICU/PICU/ICU/OR.
Key inclusion criteria (24 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips IntelliVue X3 Patient MonitorAll 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. | Device | Subject Group 1, Subject Group 2, Subject Group 3 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shakun Karki contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Hernandez, MBA (210-517-4405, natalie.hernandez@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Philips NIBP System Equivalence to Radial Arterial Line (time frame: Through study completion, approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.