Cardiogenic Shock
Conditions
Brief summary
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Detailed description
The objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module, which can replace invasive hemodynamic monitoring in the future.
Interventions
OTHERData Acquisition
Develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module.
Sponsors
Abiomed Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ongoing or planned intensive care management with Impella support 2. Presence or planned placement of a cardiac output measurement 1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement) 2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods
Exclusion criteria
1. Age \< 18 years 2. Pregnancy 3. Anticipated support duration \<24 h
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of hemodynamic parameters (Cardiac Output in l/min) | From Impella insertion unitl Impella support is permanently weaned, on average 2 days | Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access. |
| Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg) | From Impella insertion unitl Impella support is permanently weaned, on average 2 days | Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access. |
| Collection of hemodynamic parameters (Mixed Venous Saturation in %) | From Impella insertion unitl Impella support is permanently weaned, on average 2 days | Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access. |
| Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 ) | From Impella insertion unitl Impella support is permanently weaned, on average 2 days | Synchronous data acquisition of the Impella system parameters (pressure measurement, motor current, operating data) and the monitoring system (Philipps IntelliVue) using a network module (HighDim) that is connected by either a wired or wireless access. |
Secondary
| Measure | Time frame |
|---|---|
| Rate of Patient Survival | Once the Impella support is permanently weaned, on average 2 days |
Countries
Germany, Italy, Switzerland
Contacts
CONTACTAndreas Goetzenich, MD, PhD, MBA, FAHA, FESC
CONTACTKirstin Starke
PRINCIPAL_INVESTIGATORAlexander Kersten, MD
Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin
Outcome results
None listed