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临床试验/NCT05945303
NCT05945303已完成不适用

Correlation Between Internal Jugular Vein Ultrasound and Electrical Cardiometry in Assessment of Fluid Responsiveness in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Egymedicalpedia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Reliability of predicting fluid responsiveness

研究概览

简要总结

Coronary artery bypass graft (CABG) surgery is one of the most frequently performed cardiac surgery procedures worldwide. CABG has been used for more than 40 years to relieve symptoms and to reduce the risk of death in patients with ischemic heart disease.

详细描述

Cardiopulmonary bypass can produce changes in fluid physiology and fluid responsiveness in patients characterized by increased interstitial fluid as a consequence of decreased cardiac output and inflammatory changes. This shift of fluid from intravascular space to the intrtstitial space, in addition to blood and fluid losses during the surgical procedure can result in an intravascular hypovolemia that requires fluid resuscitation.

Fluid management is one of the most important treatments for stabilizing hemodynamics in patients during and after cardiac surgery. Hypovolemia may leads to inadequate organ perfusion, whereas fluid overload may lead to postoperative complications such as congestive heart failure or pulmonary edema, In addition to patients who underwent cardiac surgery have a certain degree of myocardial stunning and hence cautions should be taken regarding fluid management in patients with limited cardiac reserve.

Fluid responsiveness (FR) is generally defined as an increase of 10-15% in stroke volume (SV), cardiac output (CO), or cardiac index (CI) in response to volume expansion and indicates unmasked hypovolemia or preload dependacy.

The methods for assessing fluid responsiveness have been evolved from static and volume parameters such as central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP), inferior vena cava (IVC) and superior vena cava (SVC) diameters, right ventricular end-diastolic volume and right ventricular end-diastolic volume, which are unable to predict fluid responsiveness to dynamic indices such as pulse pressure variation (PPV),stroke volume variation (SVV), Pleth variability index (PVI) and aortic blood flow which is based on heart-lung interactions during mechanical ventilation, which have amodest degree of accuracy.

Techniques based on either a virtual or real fluid challenge such as passive led raising (PLR) and rapid fluid challenge (100-250cc) have a high degree of accuracy in predicting fluid responsiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, 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

  • Adult patients (above 18 years old to be able to provide advanced informed consent Planned for elective CABG surgery) both male and female will be included in the study

排除标准

  • Severely reduced preoperative left ventricular ejection fraction (< 40 %).
  • Patients who will develop any complication after fluid infusion as pulmonary edema and heart failure will be excluded from the study.
  • Significant cardiac arrhythmia.
  • Significant valvular heart disease.
  • Clinically evident pulmonary disease.
  • Bilaterally inserted venous catheters (jugular or subclavian vein).
  • History of radiotherapy or surgery of the neck region.
  • Inability to obtain interpretable ultrasound images due to a difficult acoustic window.

结局指标

主要结局

Reliability of predicting fluid responsiveness

时间窗: 2 hours after the coronary artery bypass graft surgery

to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry.

次要结局

  • Thoracic fluid content(2 hours after the coronary artery bypass graft surgery)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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