The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia: a Pilot Study (VENTMICS)

Jessa Hospital

Status: Completed

Conditions: Myocardial Ischemia; Hypoxia

Treatments: Procedure: Discontinued ventilation; Procedure: Continued ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05109715

f/2021/118

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years old
• Patients undergoing their first elective endo-CABG procedure
• Patients capable of signing the informed consent
• Patients able to speak Dutch or French

Exclusion criteria

• Ongoing participation in another trial
• Ejection fraction < 50%
• Lung diseases (COPD, asthma)
• Use of corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 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 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

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 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

Treatment:

Procedure: Continued ventilation