Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Abiomed Inc.
- 入组人数
- 125
- 试验地点
- 9
- 主要终点
- Collection of hemodynamic parameters (Cardiac Output in l/min)
研究概览
简要总结
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age < 18 years
- •Anticipated support duration <24 h
结局指标
主要结局
Collection of hemodynamic parameters (Cardiac Output in l/min)
时间窗: 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)
时间窗: 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 %)
时间窗: 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 )
时间窗: 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.
次要结局
- Rate of Patient Survival(Once the Impella support is permanently weaned, on average 2 days)