Actively Recruiting
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
Led by Philips Clinical & Medical Affairs Global · Updated on 2026-02-27
205
Participants Needed
4
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.
CONDITIONS
Official Title
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Indication for non-invasive blood pressure cuff
- Indication for a radial arterial line
- Ability to understand and speak the local language or Spanish (for US sites) to provide informed consent
- Enrollment targets include at least 30% of participants over 65 years and 30% under 65 years of age
- Enrollment targets include at least 30% male and 30% female participants
- Enrollment targets for cuff sizes: Adult Small (19-27 cm) = 28; Adult (25-34 cm) = 31; Adult Large Short (30-40 cm with severely conical arm) = 35; Adult Large (32-43 cm) = 38
- At least 40% of subjects within each cuff size must have limb circumference in the upper half of the cuff range
- At least 40% of subjects within each cuff size must have limb circumference in the lower half of the cuff range
- At least 10% of systolic blood pressure measurements ≤ 100 mmHg
- At least 10% of systolic blood pressure measurements ≥ 160 mmHg
- At least 10% of diastolic blood pressure measurements ≤ 70 mmHg
- At least 10% of diastolic blood pressure measurements ≥ 85 mmHg
You will not qualify if you...
- Emergency surgery
- Surgeries where both arms are tucked
- Inability to place the Philips AMC due to anatomy or condition
- Known pregnancy or lactating women (self-report)
- Treatment with an intra-aortic balloon pump
- Aortic and mitral regurgitation greater than 2nd degree, if known
- Measurements taken in the lateral position
- Arterial line pressure system exceeding ±2 mmHg at 100 mmHg when tested
- Participation in another investigational drug or device study interfering with endpoints
- Upper arm circumference less than 19 cm or greater than 43 cm
- Body mass index over 45
- Average baseline lateral difference for systolic blood pressure greater than 15 mmHg or diastolic greater than 10 mmHg
- Investigator discretion for any other disqualifying reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
3
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
4
LMU Klinikum , Campus Großhadern
München, Bavaria, Germany, 81377
Actively Recruiting
Research Team
L
Lea Egger
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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