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临床试验/NCT05968040
NCT05968040尚未招募不适用

Point Of Care Ultrasound For Prediction Of Fluid Responsiveness in Off Pump Coronary Artery Bypass Grafting Surgery, Comparison Between Carotid Doppler Peak Velocity And IVC Distensibility Index

Ain Shams University0 个研究点目标入组 40 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
cardiac outputby transthoracic echocardiography

研究概览

简要总结

To exclude hypovolemia before starting off pump coronary artery grafting surgeries by an efficient and good predictive test. We will assess the sensitivity and specificity of dynamic IVC-derived parameters (dispensability index) in comparison to carotid Doppler peak velocity as predictors of fluid response before skin incision in patients undergoing off Pump cardiac surgery.

详细描述

Monitoring We will monitor all patients using, invasive blood pressure, pulse oximeter, central venous pressure (CVP), 5 leads Electrocardiogram ECG and capnogram.

Anesthetic technique:

Anesthesia will be inducted by; lidocaine 1.5 mg/Kg, fentanyl 10 mic/kg, propofol (2 mg/kg) and atracurium (0.5 mg/kg). After good muscle relaxation, intubation will be done smoothly. Mechanical ventilation parameters will be fixed in all patients during the study period. Tidal volume will be adjusted to 10 ml/kg without positive end expiration pressure. End tidal carbon dioxide will be kept around 35-40 centimeter water(cmH2O). Anesthesia will be maintained by Sevoflurane 2% minimal alveolar concentration(MAC), atracurium infusion; 0.05-0.01 mg/kg/min and fentanyl infusion rate; 1 mic/kg/hour.

Study measurements:

After induction of anesthesia we will perform the measurement of the diameter of the inferior vena cava through standard ultrasonic techniques. The M-mode portable ultrasound 1-5 megahertz (MHz) transthoracic phased-array transducer probe will be positioned longitudinally along the xiphoid process when the patient is supine. The diameter of the inferior vena cava will be measured at 2 cm close to the entrance of the right atrium. Ultrasound images will be taken at the end of inspiration (Dmax) and at the end expiration (Dmin) to calculate the inferior vena cava dispensability index (dIVC), and will be recorded before and after fluid challenge test of 5 ml/kg crystalloid within 15 min. The inferior vena cava (IVC) distensibility index (IVC-DI) will be calculated using the formula: IVC-DI = IVCmax - IVCmin/ IVCmin. The indices will be expressed as a percentage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with accepted cardiac capacity (EF >45%)
  • Patients scheduled for off pump open heart surgeries for coronary artery grafting

排除标准

  • age under 18 years,
  • patients with poor cardiac capacity
  • patients suffering any type of arrhythmias
  • preoperative left ventricular dilatation (end-diastolic dimension ≥6 cm)
  • preoperative severe tricuspid valve regurgitation,
  • preoperative right ventricular dysfunction
  • patients with high intrathoracic pressure e.g.chronic obstructive pulmonary disease (COPD).

结局指标

主要结局

cardiac outputby transthoracic echocardiography

时间窗: immediately after fluid administration

cardiac output = stroke volume x heart rate

cardiac output by transthoracic echocardiography

时间窗: immediately before fluid administration

cardiac output = stroke volume x heart rate

次要结局

  • carotid peak velocity by ultrasound(immediately after fluid administration)
  • heart rate(immediately after fluid administration)
  • inferior vena cava diameter by ultrasonography(immediately after fluid administration)
  • central venous pressure measurement(immediately after fluid administration)
  • mean blood pressure(immediately after fluid administration)
  • usage of ionotropic support (adrenalin, noreadrenalin,dopamine and dubotamine)(during the intraoperative period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

RAMY AHMED

Assistant Professor of Anesthesia

Ain Shams University

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