The goal of this study is to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure
Ventilation is continued from going on CPB until clamping of the ascending aorta with tidal volume 3ml/kg ideal body weight, Fraction of inspired oxygen (FiO2) 50%, respiratory rate 5/min and Inspiratory:Expiratory (I/E) ratio 1/2.
Jessa Hospital
Hasselt, Belgium
The influence of continued mechanical ventilation on the release of cardiac troponin T (cTn-T)
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.
Time frame: Until 24 hours after clamping the aorta
The influence of continued mechanical ventilation on the release of creatine kinase-myocardial band (CK-MB)
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.
Time frame: Until 24 hours after clamping the aorta
The influence of continued mechanical ventilation on the release of heart-type fatty acid-binding protein (hFABP)
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.
Time frame: Until 5 hours after clamping the aorta
The influence of continued mechanical ventilation on lipid peroxidation
Lipid peroxidation is measured using the malondialdehyde assay.
Time frame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
The influence of continued mechanical ventilation on the redox balance
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.
Time frame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta) ]
The influence of continued mechanical ventilation on the partial pressure of oxygen (pO2)
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pO2 is represented in mmHg. If pO2 is lower than 60 mmHg, then hypoxemia is present.
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The influence of continued mechanical ventilation on the partial pressure of carbon dioxide (pCO2)
pCO2 is represented in mmHg.
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The influence of continued mechanical ventilation on the pH
The pH will measure the acidity.
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The influence of continued mechanical ventilation on lactate
Lactate is represented in mmol/L.
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The occurence of myocardial infarction
This is based on the Fourth universal definition of myocardial infarction (2018).
Time frame: Until 30 days after surgery
The occurence of mortality
All-cause mortality is evaluated.
Time frame: Until 30 days after surgery
The occurence of neurological complications
Neurological complications include cerebrovascular accident (CVA), transient ischemic attack (TIA), delirium, epilepsy
Time frame: Until 30 days after surgery
The occurence of graft failure
Graft failure describes total graft occlusion that prevents blood flow through the graft to the revascularized part of the heart.
Time frame: Until 30 days after surgery