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临床试验/CTRI/2023/07/055738
CTRI/2023/07/055738已完成不适用

Cerebral Oxygenation Monitoring during Coronary Artery Bypass Grafting and its correlation with Hematocrit, Mean Arterial Pressure and Partial pressure of Oxygen in arterial blood

SMS Medical College1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年1月9日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
• Mean regional oxygen saturation of right side of frontal lobe [rSo2R]

研究概览

简要总结

Coronary Artery Bypass Grafting (CABG) is a widelyperformed surgical procedure aimed at restoring blood flow to the heart musclesby bypassing obstructed or narrowed coronary arteries. Despite advancements insurgical techniques and perioperative care, cerebral complications during andafter CABG surgery remain a significant concern.Near-infrared spectroscopy (NIRS) is alsonon-invasive monitoring technique that measures regional cerebral oxygensaturation (rSO2) and provides insights into cerebral oxygenation. By shiningnear-infrared light into the scalp and measuring the reflected light, NIRSallows continuous monitoring of regional oxygenation in real-time. NIRS optodecontains an infrared light source which is transmitted through the skull to theouter layer of the cerebral cortex. The same optode has different sensors whichdistinguish between the photons reflected from skin, muscle, skull, dura andbrain.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient willing to give consent
  • American Society of Anaesthesiologists (ASA) grade II.
  • Patient’s body weight 40-70 Kgs
  • Patients undergoing Coronary Artery Bypass Grafting surgery.

排除标准

  • Emergency surgery
  • Evidence of carotid disease
  • History of cerebrovascular accident or syncope
  • Evidence of any liver or kidney disease
  • Acute coronary syndrome
  • Severe uncontrolled hypertension (MAP>150 mmHg).

结局指标

主要结局

• Mean regional oxygen saturation of right side of frontal lobe [rSo2R]

时间窗: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean regional oxygen saturation of left side of frontal lobe [rSo2L]

时间窗: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean haematocrit

时间窗: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean arterial blood pressure [MAP]

时间窗: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean partial pressure of oxygen in arterial blood [PaO2]

时间窗: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

• Mean cardiopulmonary bypass flows [CPB flows]

时间窗: Baseline before induction of anaesthesia (FiO2 21%) | After induction of anaesthesia with a FiO2 of 100% | After induction of anaesthesia with a FiO2 of 50% | At the initiation of CPB | On CPB during cooling at 350C | On CPB during hypothermia at 320C | On CPB during rewarming at 360C | After weaning from CPB with a FiO2 of 100% | After weaning from CPB with a FiO2 of 50%

次要结局

  • Use Of ionotropes(Intraoperatively)

研究者

申办方类型
Government medical college

研究点 (1)

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