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The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia

NCT ID: NCT05417217

Last Updated: 2024-11-29

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

TERMINATED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2024-11-09

Brief Summary

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

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Coronary Artery Disease 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 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

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 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

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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Discontinued ventilation

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jessa Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alaaddin Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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f/2022/096

Identifier Type: -

Identifier Source: org_study_id