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

Jessa Hospital

Status: Terminated

Conditions: Coronary Artery Disease; Myocardial Ischemia; Hypoxia; Cardiovascular Diseases

Treatments: Procedure: Discontinued ventilation; Procedure: Continued ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05417217

f/2022/096

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Procedure: Discontinued ventilation

Ventilation group

Experimental group

Description:

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

Treatment:

Procedure: Continued ventilation