Status:
RECRUITING
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Cardiac Surgery, Non-Cardiac ICU
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
Primary Objective: • To evaluate equivalence of BP measurements (Systolic Blood Pressure \[SBP\], Diastolic Blood Pressure \[DBP\], and Mean Arterial Pressure \[MAP\]) derived from the Philips AMC to...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 2 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT06895590
Start Date
October 2 2025
End Date
February 1 2026
Last Update
December 10 2025
Active Locations (4)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Duke University Health System
Durham, North Carolina, United States, 27710
3
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
4
LMU Klinikum
München, Bavaria, Germany, 81377