Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Abiomed Inc.
- Enrollment
- 125
- Locations
- 9
- Primary Endpoint
- Collection of hemodynamic parameters (Cardiac Output in l/min)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ongoing or planned intensive care management with Impella support
- •Presence or planned placement of a cardiac output measurement
- •Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
- •Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods
Exclusion Criteria
- •Age < 18 years
- •Anticipated support duration <24 h
Outcomes
Primary Outcomes
Collection of hemodynamic parameters (Cardiac Output in l/min)
Time Frame: 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)
Time Frame: 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 %)
Time Frame: 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 )
Time Frame: 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 Outcomes
- Rate of Patient Survival(Once the Impella support is permanently weaned, on average 2 days)