Comparison of Dynamic Fluid Responsiveness Assessed by Electrical Impedance Tomography and Transpulmonary Thermodilution in Postoperative of Coronary Artery Bypass Grafting Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Difference between the variation of the stroke volume and impedance variation (mean difference in %)
研究概览
简要总结
The purpose of this study is to evaluate the stroke volume variation measured by both methods: transpulmonary thermodilution and electrical impedance tomography (EIT), during fluid responsiveness maneuvers and after fluid replacement in the immediate postoperative of coronary artery bypass grafting (CABG) patients. Patients will be hemodinamically monitored with the VolumeView set in combination with EV1000 clinical platform and the display of valuable volumetric parameters (Edwards Lifesciences, California, USA). Simultaneoulsy, patients will be monitored with Enlight Electrical Impedance Tomography (Timpel, São Paulo, Brazil). Hemodynamic data will be assessed at baseline 1, one minute after the passive leg raising maneuver, after PEEP increment, and after 500 mL of Lactated Ringer's (bolus infusion). Blood gases sample will be assessed before and immediatly after the protocol.
详细描述
In the ICU, immediately after CABG surgery, patients are submitted to mechanical ventilation (volume-controlled mode with tidal volume = 8mL/Kg of PBW, PEEP = 8cmH2O and FiO2 = 60%, respiratory rate to maintain PaCO2 = 35 - 45 mmHg); hemodynamically monitored with VolumeView set in combination with EV1000 clinical platform and the display of volumetric parameters (Edwards Lifesciences, California, USA). Electrical impedance tomography monitoring (Enlight, Timpel, São Paulo, Brazil) is performed with a pair of electrodes belt attached around the thorax at 4Th - 6Th intercostal space, and a flow sensor attached between the orotracheal tube and the Y connector from the ventilator.
Before initiate the protocol, patients are submitted to a bolus of usual care doses of sedation and muscular blockage (Fentanyl, Midazolam and Cisatracurium).
To assess fluid responsiveness patients will be submitted to two different maneuvers applied in a random way: Passive Leg Raising (PLR) ant PEEP increment (PEEP). And after these maneuvers patients will receive a bolus of 500 ml of Lactated Ringer's.
Measurements are performed one minute after each of these conditions:
- Baseline: before both fluid responsiveness maneuvers, before and after Lactated Ringer infusion, patient is positioned in 450 semi-recumbent position;
- PLR: Fluid responsiveness maneuver which patient is positioned from 450 semi-recumbent position to dorsal decubitus and the legs are raised at 450;
- PEEP increment: Fluid responsiveness maneuver which consisted in increased the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 450 semi-recumbent position
- Infusion of 500 mL of Ringer's; 450 semi-recumbent position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective CABG surgery
- •Age greater than 18 years old and less than 80 years old
- •Written inform consent
排除标准
- •Previous pulmonary disease or pulmonary hypertension
- •Previous renal replacement therapy
- •Left ventricular ejection fraction < 40%
- •Body mass index > 40 kg/m2
- •Atrial fibrillation
- •Presence of cardiac pacemaker or another implantable electronic device
- •Bleeding associated to hemodynamic instability
- •Cardiac arrest or suspicion of neurological alteration
- •Hemodynamic instability (norepinephrine dose > 0.5 mcg/Kg/min)
结局指标
主要结局
Difference between the variation of the stroke volume and impedance variation (mean difference in %)
时间窗: within 2 hours after patient admission in the ICU
Mean difference between stroke volume variation and impedance variation during different fluid responsiveness maneuvers, baseline condition and after volume infusion assessed by transpulmonary thermodilution and pulse contour method for stroke volume using VolumeView system, and electrical impedance parameters measured by Electrical impedance tomography for impedance variation
Correlation between the variation of the stroke volume and impedance variation
时间窗: within 2 hours after patient admission in the ICU
Correlation test between the change (delta) of stroke volume and impedance variation during different fluid responsiveness maneuvers, baseline condition and after volume infusion assessed by transpulmonary thermodilution and pulse contour method for stroke volume using VolumeView system, and electrical impedance parameters measured by Electrical impedance tomography for impedance variation
次要结局
- Agreement between stroke volume variation (delta) (mean difference in %, CI and limits of agreement)(within 2 hours after patient admission in the ICU)
- Safety of assessment stroke volume by EIT during fluid responsiveness Test (delta of Sodium, in mEq/mL)(within 2 hours after patient admission in the ICU)
- Agreement between stroke volume variation (SVV) delta during PLR maneuver and with the infusion of volume(within 2 hours after patient admission in the ICU)
- To evaluate the ability of increment of PEEP to predict fluid responsiveness(within 2 hours after patient admission in the ICU)
研究者
Ludhmila Abrahão Hajjar
Associate Professor of Cardiology Department
University of Sao Paulo