Comparing a Philips upper-arm advanced monitoring cuff with invasive radial arterial line measurements
Official title: The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
Run by Philips Clinical & Medical Affairs Global · NCT06895590 · Data updated 2026-11-12
This study will test if a new Philips upper-arm monitoring cuff can match invasive radial arterial line blood pressure and fluid-responsiveness measurements in adult surgical and ICU patients who need both methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 205 (estimated) |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Status | Recruiting |
| Started | October 2, 2025 |
| Main results expected | February 2026 |
| Study ends | February 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT06895590 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older who clinically require both a noninvasive blood pressure cuff and a radial arterial line and can provide informed consent are eligible, with targeted enrollment to ensure representation across age groups, sexes, and cuff sizes.
✕Probably not a fit
Patients who do not need a radial arterial line, children under 18, or those whose arm size or anatomy prevents use of the study cuffs are unlikely to benefit from participation.
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 will collect paired measurements from the Philips Advanced Monitoring Cuff (AMC), a standard oscillometric non-invasive blood pressure cuff, and an invasive radial arterial line in adults undergoing surgery or critical care who require both devices. Primary comparisons focus on systolic, diastolic, and mean arterial pressure, while secondary analyses include pulse rate, pulse pressure variation, and stroke volume variation, plus trending agreement. The protocol also records time to apply and time to first measurement, device safety events, and user satisfaction, and aims to enroll stratified cohorts across cuff sizes, ages, and sex. Data will be pooled across three U.S. academic medical centers to create a research dataset for future hemodynamic algorithm development.
Why it matters
Potential benefit: If successful, the device could give clinicians near-arterial-quality blood pressure and fluid-responsiveness data noninvasively, reducing reliance on invasive radial lines for some patients.
How similar studies have gone: Previous work on advanced noninvasive cuff technologies and pulse-contour methods has shown mixed but sometimes promising agreement with arterial lines, so direct device-specific validation is still needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years and older * Indication for NIBP cuff * Indication for a radial arterial line * Subject or legal authorized representative is able to understand and speak the local language (also Spanish for US sites) to provide voluntary written informed consent prior to study procedures The following stratification criteria must be met across the study sites and hence targeted enrollment may be required: * Age of every patient 18+; at least 30% \> 65 years, 30% ≤ 65 years * At least 30% male, 30% female * Minimum number of subjects needed to test each size cuff (per ISO81060-2:2018/AMD2:2024, based on limb circumference range): * Adult Small (19-27 cm) = 165\*\[8/(2\*24)\] = 28 * Adult (25-34 cm) = 165\*\[9/(2\*24)\] = 31 * Adult Large Short (30-40 cm with severely conical arm) = 165\*\[10/(2\*24)\] = 35 * Adult Large (32-43 cm) = 165\*\[11/(2\*24)\] = 38 * At least 40% of the subjects within each cuff size shall have a limb circumference that lies within the upper half of the specified range of use of the cuff * At least 40% of the subjects within each cuff size shall have a limb circumference within the lower half of the specified range of use of the cuff * At least 10% SBP measurements ≤ 100 mmHg * At least 10% SBP measurements ≥ 160 mmHg * At least 10% DBP measurements ≤ 70 mmHg * At least 10% DBP measurements ≥ 85 mmHg Exclusion Criteria: * Emergency surgery * Surgeries in which both arms are tucked * Inability to place the Philips AMC appropriately due to subject anatomy or condition * Known pregnancy or lactating women (self-report) * Patients treated with an intra-aortic balloon pump * Aortic and mitral regurgitation (\> 2nd degree), if known * Measurements taken in the lateral position * Pressure of the arterial line system, when tested at 100 mmHg with the VeriCal device, exceeds the +/- 2 mmHg threshold * Currently participating in an investigational drug or another device study that clinically interferes with the study endpoints * Upper arm circumference \< 19 cm or \> 43 cm * BMI \> 45 * If the average of 3 baseline NIBP lateral difference measurements for SBP is \> 15 mmHg or for DBP is \> 10 mmHg * At the PI's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above
Where it's running
-
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States Recruiting -
Duke University Health System
Durham, North Carolina, United States Recruiting -
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States Recruiting -
LMU Klinikum , Campus Großhadern
München, Bavaria, Germany Recruiting
Study contacts
- Study coordinator: Lea Egger
- Email: lea.egger@philips.com
- Phone: +49 1722314318
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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.