The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
Philips Clinical & Medical Affairs Global
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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 a…
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)
- UVA HealthCharlottesville, Virginia
- Universitätsklinikum Hamburg EppendorfHamburg, Free and Hanseatic City of Hamburg