RecruitingNCT06895603
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
Sponsor
Philips Clinical & Medical Affairs Global
Enrollment
75 participants
Start Date
Oct 28, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria10
- 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
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Interventions
DEVICEPhilips Advanced Monitoring Cuff (AMC)
The Philips AMC is a Class II (USA) and Class IIb (EU) medical device that is a non-invasive, semirigid disposable upper arm cuff with an integrated pneumatic actuator enabling hydraulic coupling of tissue pressure waveforms from the upper arm tissue.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06895603
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