The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
Trial Parameters
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 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 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