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

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

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

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease; Hypoxia
• Intervention / Treatment: Procedure: Discontinued ventilation; Procedure: Continued ventilation

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jade Claessens, MSc; Phone Number: 011 33 71 07; Email: jade.claessens@uhasselt.be
• Study Contact Backup: Name: Alaaddin Yilmaz, MD; Phone Number: 011 33 71 04; Email: alaaddin.yilmaz@jessazh.be

Study Locations

• Belgium
  • Hasselt, Belgium
    • Recruiting
    • Jessa Hospital
    • Contact: Alaaddin Yilmaz, MD; Phone Number: +3211337104; Email: alaaddin.yilmaz@jessazh.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Until 5 hours after clamping the aorta
The influence of continued mechanical ventilation on lipid peroxidation	Lipid peroxidation is measured using the malondialdehyde assay.	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.	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)	pO2 is represented in mmHg. If pO2 is lower than 60 mmHg, then hypoxemia is present.	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.	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.	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.	Until the end of surgery (on average until 203 minutes after the start of the surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurence of myocardial infarction	This is based on the Fourth universal definition of myocardial infarction (2018).	Until 30 days after surgery
The occurence of mortality	All-cause mortality is evaluated.	Until 30 days after surgery
The occurence of neurological complications	Neurological complications include cerebrovascular accident (CVA), transient ischemic attack (TIA), delirium, epilepsy	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.	Until 30 days after surgery

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Investigators: Principal Investigator: Alaaddin Yilmaz, MD, Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac surgery; Ventilation; Minimally invasive cardiac surgery; Endoscopic coronary artery bypass grafting; Harlequin syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Signs and Symptoms, Respiratory; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Ischemia; Hypoxia
• Other Study ID Numbers: f/2022/096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No