VENTMICS-II: The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia

Sponsor

Jessa Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05417217

Collaborator

(none)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Hypoxia	Procedure: Discontinued ventilation Procedure: Continued ventilation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Totally Endoscopic Coronary Artery Bypass Grafting

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group 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 CPB, after clamping the aorta, before unclamping the aorta, after the operation, 5 h after clamping the aorta, 12 hours after clamping the aorta, and 24 hours after aortic clamping	Procedure: Discontinued ventilation Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure
Experimental: Ventilation group 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 CPB, after clamping the aorta, before unclamping the aorta, after the operation, 5 h after clamping the aorta, 12 hours after clamping the aorta, and 24 hours after aortic clamping	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.

Arm

Intervention/Treatment

Active Comparator: Control group

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 CPB, after clamping the aorta, before unclamping the aorta, after the operation, 5 h after clamping the aorta, 12 hours after clamping the aorta, and 24 hours after aortic clamping

Procedure: Discontinued ventilation

Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure

Experimental: Ventilation group

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 CPB, after clamping the aorta, before unclamping the aorta, after the operation, 5 h after clamping the aorta, 12 hours after clamping the aorta, and 24 hours after aortic clamping

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.

Outcome Measures

Primary Outcome Measures

The influence of continued mechanical ventilation on the release of cardiac troponin T (cTn-T) [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 release of creatine kinase-myocardial band (CK-MB) [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) [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 [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 redox balance [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 partial pressure of oxygen (pO2) [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) [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 [Until the end of surgery (on average until 203 minutes after the start of the surgery)]
The pH will measure the acidity.
The influence of continued mechanical ventilation on lactate [Until the end of surgery (on average until 203 minutes after the start of the surgery)]
Lactate is represented in mmol/L.

Secondary Outcome Measures

The occurence of myocardial infarction [Until 30 days after surgery]
This is based on the Fourth universal definition of myocardial infarction (2018).
The occurence of mortality [Until 30 days after surgery]
All-cause mortality is evaluated.
The occurence of neurological complications [Until 30 days after surgery]
Neurological complications include cerebrovascular accident (CVA), transient ischemic attack (TIA), delirium, epilepsy
The occurence of graft failure [Until 30 days after surgery]
Graft failure describes total graft occlusion that prevents blood flow through the graft to the revascularized part of the heart.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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