ICU, Pulmonary Artery Catheter (PAC), Swan-Ganz Catheter
Conditions
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.
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.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoints | Approximately 8 months for accrual and follow-up | The comparison of cardiac output between the Philips AMC and PAC |
Countries
Germany, United States
Contacts
CONTACTLea Egger
Outcome results
None listed