The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Totally Endoscopic Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- The influence of continued mechanical ventilation on lactate
研究概览
简要总结
The goal of this study is to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
详细描述
Coronary artery bypass grafting (CABG) surgery is one of the main treatment options for patients suffering from coronary artery disease, a condition characterized by a build-up of cholesterol in the coronary arteries of the heart that affects 126 million people worldwide each year. During this procedure, cardiopulmonary bypass (CPB) takes over the function of the heart and lungs. In recent years, there has been a huge focus on reducing surgical trauma in this procedure, leading to the emergence of minimally invasive cardiac surgery (MICS) such as endoscopic CABG (endo-CABG). In these techniques, peripheral CPB with femoral arterial cannulation is the most commonly used strategy. However, the use of retrograde arterial perfusion is not without risk. It can cause that the upper part of the body only receives deoxygenated blood. The effect on the heart is not yet fully known. The hypoxemia could cause myocardial ischemia and this could damage the heart muscle cells.
It is reported in the literature that establishing adequate ventilation from the initiation of CPB to cardiac arrest can resolve this phenomenon. This approach was investigated in a recently performed double-blinded, randomized, controlled pilot study (n=10) of our research group. However, a larger randomized controlled trial was needed. Therefore, this research aims to investigate the effect of continued 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
- •Patients older than 18 years old
- •Patients undergoing their first elective endo-CABG procedure using peripheral cannulation for CPB
- •Patients who are able to give their informed consent
- •Patients who speak Dutch or French
排除标准
- •Patients participating in another clinical trial
- •Patients taking corticosteroids
- •Patients with an ejection fraction < 25%
- •Patients with lung diseases (chronic obstructive pulmonary disease (COPD), asthma)
- •Patients where groin cannulation is not possible
结局指标
主要结局
The influence of continued mechanical ventilation on lactate
时间窗: Until the end of surgery (on average until 203 minutes after the start of the surgery)
Lactate is represented in mmol/L.
The influence of continued mechanical ventilation on the release of cardiac troponin T (cTn-T)
时间窗: Until 24 hours after clamping the aorta
Cardiac troponin T is represented in ng/L. If the value of cTn-T exceeds 14 ng/L, then cTn-T is able to detect myocardial ischemia at the predefined time points.
The influence of continued mechanical ventilation on the redox balance
时间窗: Until unclamping the aorta (on average until 64 minutes after clamping the aorta) ]
superoxide dismutase 1 and 2 (SOD1, SOD2), nuclear factor erythroid 2-related factor 2 (Nrf2), catalase (CAT), glutathione peroxidase (GPx), NADPH oxidase 2 and 4 (NOX2, NOX4), heme oxygenase-1 (HO-1), NAD(P)H quinone oxidoreductase 1 (NQO-1)) will be studied to determine the redox balance.
The influence of continued mechanical ventilation on the release of creatine kinase-myocardial band (CK-MB)
时间窗: Until 24 hours after clamping the aorta
Creatine kinase-myocardial (CK-MB) band is represented in µg/L. If the value of CK-MB exceeds 6.2 µg/L, then CK-MB is able to detect myocardial ischemia at the predefined time points.
The influence of continued mechanical ventilation on the release of heart-type fatty acid-binding protein (hFABP)
时间窗: Until 5 hours after clamping the aorta
Heart-type fatty acid-binding protein (hFABP) is represented in ng/L. If the value of hFABP exceeds 6 ng/L, then hFABP is able to detect myocardial ischemia at the predefined time points.
The influence of continued mechanical ventilation on lipid peroxidation
时间窗: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
Lipid peroxidation is measured using the malondialdehyde assay.
The influence of continued mechanical ventilation on the partial pressure of oxygen (pO2)
时间窗: Until the end of surgery (on average until 203 minutes after the start of the surgery)
pO2 is represented in mmHg. If pO2 is lower than 60 mmHg, then hypoxemia is present.
The influence of continued mechanical ventilation on the partial pressure of carbon dioxide (pCO2)
时间窗: Until the end of surgery (on average until 203 minutes after the start of the surgery)
pCO2 is represented in mmHg.
The influence of continued mechanical ventilation on the pH
时间窗: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The pH will measure the acidity.
次要结局
- The occurence of neurological complications(Until 30 days after surgery)
- The occurence of graft failure(Until 30 days after surgery)
- The occurence of myocardial infarction(Until 30 days after surgery)
- The occurence of mortality(Until 30 days after surgery)