The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
Recruiting now
Conditions studied: Non-cardiac Surgical, Intensive Care Unit (ICU)
In brief
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.
Key facts
- Study ID
- NCT06895590
- Run by
- Philips Clinical & Medical Affairs Global
- People needed
- 205
- Starts
- 2025-10-02
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Duke University Health System — Durham, North Carolina, United States (enrolling)
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (enrolling)
- LMU Klinikum , Campus Großhadern — München, Bavaria, Germany (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.