An interventional study of Continued ventilation and Discontinued ventilation in Myocardial Ischemia and Hypoxia, sponsored by Jessa Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Jessa Hospital · Not applicable, Interventional, and Treatment
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.
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.
3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.
This study's enrollment of 14 is below the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →Jessa Hospital is the lead sponsor of 85 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure. Blood will be drawn: * At baseline: before general anaesthesia * After start of heart-lung machine * After clamping the aorta * Before unclamping the aorta * After the operation * 5 h after clamping the aorta * 12 hours after clamping the aorta * 24 hours after aortic clamping * 48h after clamping the aorta * 72 hours after clamping the aorta
Procedure: Discontinued ventilation
Ventilation is continued from going on CPB until clamping of the ascending aorta. Blood will be drawn: * At baseline: before general anaesthesia * After start of heart-lung machine * After clamping the aorta * Before unclamping the aorta * After the operation * 5 h after clamping the aorta * 12 hours after clamping the aorta * 24 hours after aortic clamping * 48h after clamping the aorta * 72 hours after clamping the aorta
Procedure: Continued ventilation
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.
Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure
The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)
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.
Time frame: Until 72 hours after clamping the aorta
The detection of myocardial ischemia using Heart-type Fatty Acid Binding Protein (hFABP)
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.
Time frame: Until 5 hours after clamping the aorta
The detection of myocardial ischemia using Creatine Kinase Myocardial Band (CK-MB)
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.
Time frame: Until 48 hours after clamping the aorta
The detection of myocardial ischemia using Reactive Oxygen Species (ROS)
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.
Time frame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
The occurence of hypoxemia using blood gas measurement
If the partial pressure of oxygen (PaO2) 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)
Plan to share: No
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Jessa Hospital