Inflation-based non-invasive blood pressure test compared with standard cuff method
Official title: Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
Run by Philips Clinical & Medical Affairs Global · NCT07901608 · Data updated 2026-11-12
This study tests whether the Philips iNIBP device gives BP readings that match the usual auscultatory cuff method in people aged 3 to 85.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 3 Years to 85 Years |
| Sex | All |
| Enrollment | 85 (estimated) |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 1 site (Louisville, Colorado) |
| Status | Recruiting |
| Started | October 15, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07901608 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are participants aged 3–85 with upper-arm circumference 14–43 cm who can consent or assent and understand English for study procedures.
✕Probably not a fit
Participants with arm deviations or conditions preventing proper device application may not experience benefit from the iNIBP measurements.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares inflationary-based non-invasive blood pressure measurements from the Philips iNIBP system to the reference auscultatory method. Using a same-arm, sequential measurement with two independent observers, the study evaluates bias and variability in systolic, diastolic, and mean arterial pressure. The goal is to determine equivalence of the two approaches for accurate BP assessment across a wide age range. Data will inform whether iNIBP can provide reliable blood pressure readings in routine clinical or research settings.
Why it matters
Potential benefit: If successful, the iNIBP system could offer accurate BP readings without auscultation, potentially simplifying measurement workflows.
How similar studies have gone: Past studies outside this protocol have shown mixed results; this study contributes targeted validation for the Philips iNIBP approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be 3 to 85 years of age. * Participants, parents or legal guardians of participants must be able to provide informed consent, parental permission, and/or assent form. * Participants that are between 7 and 17 (inclusive) years of age must provide assent to participate in the study. * Participants, parents or legal guardians of participants must be able to read or write in English and participants that are between the age of 7-17 must be able to understand English to provide assent. * Participant must be willing and able to comply with study procedures and duration. * Participants must have an upper arm circumference in the range of 14-43 centimeters. Exclusion Criteria: * Participant, parent or legal guardian of participant is unwilling to provide informed consent, parental permission, and/or assent. * Participants with deformities or abnormalities that may prevent proper application of the device under test. * Participants with an upper arm circumference less than 14 cm or greater than 43 cm. * Female participants who are pregnant. * Female participants who are trying to get pregnant with confirmation of positive urine pregnancy test. * Participants with known heart arrhythmias. * Participants with peripheral vascular disease. * Participants with clotting disorders. * History of bleeding disorders or personal history of prolonged bleeding from injury. * History of blood clots. * Hemophilia. * Participants that cannot tolerate sitting for up to 1-2 hours. * Participant with a blood pressure or other demographics that have already been filled. * Other known health conditions that will prevent safe participation in the study upon disclosure in screening form or verbally. * Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study. * Participants where the Korotkoff sounds (fifth phase (K5)) for determining DBP is not audible.
Where it's running
-
Element Materials Technology
Louisville, Colorado, United States Recruiting
Study contacts
- Study coordinator: Jessica Rodriguez
- Email: Jessica.Rodriguez_1@philips.com
- Phone: 857-275-9668
Similar studies
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New Non-Invasive Blood Pressure (NIBP) Enhancement for Neonates and Children
This study tests a new NIBP device enhancement in neonates and kids to see if it can measure blood pressure more accurately.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.