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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-24

Study Completion Date

2022-10-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myocardial Ischemia Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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 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

Group Type ACTIVE_COMPARATOR

Discontinued ventilation

Intervention Type PROCEDURE

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

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 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

Group Type EXPERIMENTAL

Continued ventilation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Discontinued ventilation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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