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

Launched by PHILIPS CLINICAL & MEDICAL AFFAIRS GLOBAL · Mar 19, 2025

Keywords

ClinConnect Summary

The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial is a clinical study aimed at comparing two different methods for measuring heart function and fluid levels in patients who are in the Intensive Care Unit (ICU) or who have recently had surgery. Specifically, the trial will look at how well the Philips AMC device works in comparison to the traditional Swan-Ganz catheter (PAC).

To participate in this study, you need to be an adult aged 18 or older and require one of the devices for monitoring heart function. However, if you’re having emergency surgery, if your arms are positioned in a way that makes it hard to use the devices, or if you have certain medical conditions, you may not be eligible. Participants will have the opportunity to help improve patient care by contributing to important research. If you or a family member are interested, please know that this study is not yet recruiting, so you will need to wait for more information on how to enroll.

Gender

ALL

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