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NCT Number: NCT05109715

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

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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Key information

Conditions

Myocardial Ischemia Cardiovascular Diseases Heart Diseases Hypoxia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital

Hasselt, Limburg, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continued ventilation

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.

Discontinued ventilation

Procedure

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

Primary outcomes

  1. The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)

    Time frame: Until 72 hours after clamping the aorta

    If the value of Cardiac Troponin T (cTn-T) exceeds 14 ng/L, then cTn-T is able to detect myocardial ischemia at the predefined time points.

  2. The detection of myocardial ischemia using Heart-type Fatty Acid Binding Protein (hFABP)

    Time frame: Until 5 hours after clamping the aorta

    If the value of Heart-type Fatty Acid Binding Protein (hFABP) exceeds 6 ng/L, then hFABP is able to detect myocardial ischemia at the predefined time points.

  3. The detection of myocardial ischemia using Creatine Kinase Myocardial Band (CK-MB)

    Time frame: Until 48 hours after clamping the aorta

    If the value of Creatine Kinase Myocardial Band (CK-MB) exceeds 6.2 µg/L, then CK-MB is able to detect myocardial ischemia at the predefined time points.

  4. The detection of myocardial ischemia using Reactive Oxygen Species (ROS)

    Time frame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)

    Reactive Oxygen Species (ROS) measurements include a malondialdehyde assay to assess the lipid peroxidation, an Oxystat test to analyse the total peroxide levels and a protein carbonyl assay to assess the protein damage due to cardiomyocyte dysfunction. Additionally a biopsy will be taken to analyze pro- and anti-oxidants. If a significant increase in lipid peroxidation, total peroxide levels, protein damage and/or pro- and anti-oxidants in the ventilation group compared to the control group is present, then ROS is able to detect myocardial ischemia at the predefined time points.

  5. The occurence of hypoxemia using blood gas measurement

    Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)

    If the partial pressure of oxygen (PaO2) is lower than 60 mmHg, then hypoxemia is present.

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study title

The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Endoscopic Coronary Artery Bypass Grafting (Endo-CABG): a Pilot Study

Acronym: VENTMICS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2021
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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