Clinical trial NCT05417217: The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia
Official title: The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Totally Endoscopic Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Hypoxia
Keywords: Cardiac surgery
Minimally invasive cardiac surgery
Endoscopic coronary artery bypass grafting
Harlequin syndrome
Ventilation
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The influence of continued mechanical ventilation on the release of cardiac troponin T (cTn-T)
timeFrame: Until 24 hours after clamping the aorta
measure: The influence of continued mechanical ventilation on the release of creatine kinase-myocardial band (CK-MB)
timeFrame: Until 24 hours after clamping the aorta
measure: The influence of continued mechanical ventilation on the release of heart-type fatty acid-binding protein (hFABP)
timeFrame: Until 5 hours after clamping the aorta
measure: The influence of continued mechanical ventilation on lipid peroxidation
timeFrame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
measure: The influence of continued mechanical ventilation on the redox balance
timeFrame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta) ]
measure: The influence of continued mechanical ventilation on the partial pressure of oxygen (pO2)
timeFrame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
measure: The influence of continued mechanical ventilation on the partial pressure of carbon dioxide (pCO2)
timeFrame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
measure: The influence of continued mechanical ventilation on the pH
timeFrame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
measure: The influence of continued mechanical ventilation on lactate
timeFrame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
Secondary outcomes:
measure: The occurence of myocardial infarction
timeFrame: Until 30 days after surgery
measure: The occurence of mortality
timeFrame: Until 30 days after surgery
measure: The occurence of neurological complications
timeFrame: Until 30 days after surgery
measure: The occurence of graft failure
timeFrame: Until 30 days after surgery
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
Study officials:
affiliation: Jessa Hospital
name: Alaaddin Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
References: