The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Endoscopic Coronary Artery Bypass Grafting (Endo-CABG): a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)
研究概览
简要总结
The goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
详细描述
CABG is the most effective therapy for patients suffering from coronary artery disease, a condition which annually affects 126 million people worldwide. During this surgery, cardiopulmonary bypass (CPB) takes over the function of the heart and lungs. As a result of the emergence of minimally invasive cardiac surgery (MICS) (e.g. endoscopic-CABG), peripheral CPB with femoral arterial cannulation became the most commonly utilized strategy. However, the use of retrograde arterial perfusion is not without risk. It may result in the upper body and coronary arteries being perfused with deoxygenated blood. The hypoxemia will induce myocardial ischemia and this can harm the cardiac myocytes. A solution for this inconvenience is still lacking. Literature reports that establishing adequate ventilation support should help overcome this phenomenon. However, this approach has not yet been investigated in a clinical trial. In general, this phenomenon is not well recognized in the typical surgical setting, and limited research has been done.
The goal of the proposed pilot study is to determine which method can detect myocardial ischemia at the predefined timepoints during endo-CABG. Additionally, the investigators want to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
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
- Double (Participant, Outcomes Assessor)
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
- •Age > 18 years old
- •Patients undergoing their first elective endo-CABG procedure
- •Patients capable of signing the informed consent
- •Patients able to speak Dutch or French
排除标准
- •Ongoing participation in another trial
- •Ejection fraction < 50%
- •Lung diseases (COPD, asthma)
- •Use of corticosteroids
结局指标
主要结局
The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)
时间窗: Until 72 hours after clamping the aorta
If the value of Cardiac Troponin T (cTn-T) exceeds 14 ng/L, then cTn-T is able to detect myocardial ischemia at the predefined time points.
The detection of myocardial ischemia using Heart-type Fatty Acid Binding Protein (hFABP)
时间窗: Until 5 hours after clamping the aorta
If the value of Heart-type Fatty Acid Binding Protein (hFABP) exceeds 6 ng/L, then hFABP is able to detect myocardial ischemia at the predefined time points.
The detection of myocardial ischemia using Creatine Kinase Myocardial Band (CK-MB)
时间窗: Until 48 hours after clamping the aorta
If the value of Creatine Kinase Myocardial Band (CK-MB) exceeds 6.2 µg/L, then CK-MB is able to detect myocardial ischemia at the predefined time points.
The detection of myocardial ischemia using Reactive Oxygen Species (ROS)
时间窗: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
Reactive Oxygen Species (ROS) measurements include a malondialdehyde assay to assess the lipid peroxidation, an Oxystat test to analyse the total peroxide levels and a protein carbonyl assay to assess the protein damage due to cardiomyocyte dysfunction. Additionally a biopsy will be taken to analyze pro- and anti-oxidants. If a significant increase in lipid peroxidation, total peroxide levels, protein damage and/or pro- and anti-oxidants in the ventilation group compared to the control group is present, then ROS is able to detect myocardial ischemia at the predefined time points.
The occurence of hypoxemia using blood gas measurement
时间窗: Until the end of surgery (on average until 203 minutes after the start of the surgery)
If the partial pressure of oxygen (PaO2) is lower than 60 mmHg, then hypoxemia is present.
次要结局
未报告次要终点