About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Up to 75 ICU patients being monitored with a PAC and radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period
Trial design
Other
Prospective
Treatments tested in this trial
Philips Advanced Monitoring Cuff (AMC)
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Primary Endpoints
The comparison of cardiac output between the Philips AMC and PAC
Sponsors and contacts
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