Philips 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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 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
Primary outcome measure(s)
Primary Endpoints — Approximately 8 months for accrual and follow-up The comparison of cardiac output between the Philips AMC and PAC
Trial sites (2)
Facility
City
Region
Status
UVA Health
Charlottesville
Virginia
Recruiting
Universitätsklinikum Hamburg Eppendorf
Hamburg
Free and Hanseatic City of Hamburg
Recruiting
More Philips Clinical & Medical Affairs Global trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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