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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients being monitored with a pulmonary artery catheter | Up to 75 intensive care unit patients being monitored with a pulmonary artery catheter (approximately 20 patients from at least 2 sites during the roll-in phase and approximately 55 patients during the pivotal phase) will be enrolled over an estimated 8 months accrual and follow-up evaluation period. There will be no randomization in this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips Advanced Monitoring Cuff (AMC) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoints | The comparison of cardiac output between the Philips AMC and PAC | Approximately 8 months for accrual and follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lea Egger | Contact | +49 172 2314 318 | lea.egger@philips.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UVA Health | Recruiting | Charlottesville | Virginia | 22904 | United States | |
| Universitätsklinikum Hamburg Eppendorf |
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|
| Recruiting |
| Hamburg |
| Free and Hanseatic City of Hamburg |
| 20246 |
| Germany |