Status:
RECRUITING
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
ICU
Surgical Patients
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to compare cardiac output (CO), fluid responsiveness, and related measurements between the Philips AMC and PAC (Swan-Ganz) in ICU or surgical patients.
Eligibility Criteria
Inclusion
- Adults aged 18 years and older
- Indication for PAC (Swan-Ganz)
- Indication for radial arterial line
- Subject or legal authorized representative is able to understand and speak the local language (also Spanish is also accepted for US sites) to provide voluntary written informed consent prior to study procedures
Exclusion
- Emergency surgery
- ICU or surgical positioning where 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
- Measurements taken in the lateral position
- 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
- 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 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06895603
Start Date
October 28 2025
End Date
June 1 2026
Last Update
December 10 2025
Active Locations (2)
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1
UVA Health
Charlottesville, Virginia, United States, 22904
2
Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany, 20246