Mathematical Coupling of Data Between Global-End Diastolic Volume Index and Cardiac Index Calculated by Edwards EV1000
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change Left ventricular volume
研究概览
简要总结
The purpose of this study is to investigate whether cardiac output (CO) and global end diastolic volume (GEDV) determined from the same thermodilution curve by EV1000 are mathematically coupled during the infusion of fluid or inotropic agents in critically ill patients.
详细描述
Some fundamental questions remain unanswered about the mathematical analysis of the thermodilution curve and the physiological significance of the Global End Diastolic Volume ( GEDV ) .
The mathematical derivation of the Global End Diastolic Volume (GEDV) is intimately linked with the Cardiac Output (CO), because EV1000, to calculate the GEDV, uses a formula in which the CO is the term "flow " for both the calculations of Volume Thermal Intra Thoracic (ITTV) and Lung Thermal volume (PTV) .
The clinical validation of GEDV as an index of preload has been substantially based on measuring changes in GEDV and CO in response to the Fluid Challenge only in patients "volume responsive".
In this scenario, GEDV and CO may show a close correlation only on the basis of their mathematical derivation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •patient admitted in the Intensive Care Department
- •patient monitored by EV1000 trans pulmonary device
- •Systolic blood pressure (SBP) less than 90 mm Hg or SBP Drop ≥ 40 mm Hg of normal
- •decision by 1 expert intensivist physician to initiate fluid resuscitation hospital protocol or therapeutic infusion of vasopressor agent
排除标准
- •pregnancy
- •age less than 18
结局指标
主要结局
Change Left ventricular volume
时间窗: Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
To evaluate the change in cardiac function after therapeutic, life-saving fluid resuscitation or vasopressor agent infusion, Left ventricular volume measurement with echocardiography will be evaluated before and after 20 minutes starting infusion.
Change in Global end diastolic volume
时间窗: Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, global end diastolic volume will be assessed before and after 20 minutes starting infusion.
Change in Cardiac Output
时间窗: Triplicate measurement in each subject before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, cardiac output will be assessed before and after 20 minutes starting infusion.
Change Right ventricular volume
时间窗: Before and 20 minutes after therapeutic infusion of fluids or vasopressor agents
To evaluate the change in cardiac function after therapeutic life-saving fluid resuscitation or vasopressor agent infusion, Right Ventricular Volume measurement with echocardiography will be assessed before and after 20 minutes starting infusion.
次要结局
未报告次要终点
研究者
Alberto Sciusco
Medical doctor
University of Foggia