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

Primary Purpose

Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Discontinued ventilation
Continued ventilation
Sponsored by
Jessa Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases focused on measuring Cardiac surgery, Minimally invasive cardiac surgery, Endoscopic coronary artery bypass grafting, Harlequin syndrome, Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jessa HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Ventilation group

Arm 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

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

Outcomes

Primary Outcome Measures

The influence of continued mechanical ventilation on the release of cardiac troponin T (cTn-T)
Cardiac troponin T is represented in ng/L. If the value of cTn-T exceeds 14 ng/L, then cTn-T is able to detect myocardial ischemia at the predefined time points.
The influence of continued mechanical ventilation on the release of creatine kinase-myocardial band (CK-MB)
Creatine kinase-myocardial (CK-MB) band is represented in µg/L. If the value of CK-MB exceeds 6.2 µg/L, then CK-MB is able to detect myocardial ischemia at the predefined time points.
The influence of continued mechanical ventilation on the release of heart-type fatty acid-binding protein (hFABP)
Heart-type fatty acid-binding protein (hFABP) is represented in ng/L. If the value of hFABP exceeds 6 ng/L, then hFABP is able to detect myocardial ischemia at the predefined time points.
The influence of continued mechanical ventilation on lipid peroxidation
Lipid peroxidation is measured using the malondialdehyde assay.
The influence of continued mechanical ventilation on the redox balance
superoxide dismutase 1 and 2 (SOD1, SOD2), nuclear factor erythroid 2-related factor 2 (Nrf2), catalase (CAT), glutathione peroxidase (GPx), NADPH oxidase 2 and 4 (NOX2, NOX4), heme oxygenase-1 (HO-1), NAD(P)H quinone oxidoreductase 1 (NQO-1)) will be studied to determine the redox balance.
The influence of continued mechanical ventilation on the partial pressure of oxygen (pO2)
pO2 is represented in mmHg. If pO2 is lower than 60 mmHg, then hypoxemia is present.
The influence of continued mechanical ventilation on the partial pressure of carbon dioxide (pCO2)
pCO2 is represented in mmHg.
The influence of continued mechanical ventilation on the pH
The pH will measure the acidity.
The influence of continued mechanical ventilation on lactate
Lactate is represented in mmol/L.

Secondary Outcome Measures

The occurence of myocardial infarction
This is based on the Fourth universal definition of myocardial infarction (2018).
The occurence of mortality
All-cause mortality is evaluated.
The occurence of neurological complications
Neurological complications include cerebrovascular accident (CVA), transient ischemic attack (TIA), delirium, epilepsy
The occurence of graft failure
Graft failure describes total graft occlusion that prevents blood flow through the graft to the revascularized part of the heart.

Full Information

First Posted
June 9, 2022
Last Updated
October 20, 2022
Sponsor
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05417217
Brief Title
The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia
Acronym
VENTMICS-II
Official Title
The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Totally Endoscopic Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jessa Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Hypoxia
Keywords
Cardiac surgery, Minimally invasive cardiac surgery, Endoscopic coronary artery bypass grafting, Harlequin syndrome, Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm 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
Arm Title
Ventilation group
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Discontinued ventilation
Intervention Description
Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure
Intervention Type
Procedure
Intervention Name(s)
Continued ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The influence of continued mechanical ventilation on the release of cardiac troponin T (cTn-T)
Description
Cardiac troponin T is represented in ng/L. If the value of cTn-T exceeds 14 ng/L, then cTn-T is able to detect myocardial ischemia at the predefined time points.
Time Frame
Until 24 hours after clamping the aorta
Title
The influence of continued mechanical ventilation on the release of creatine kinase-myocardial band (CK-MB)
Description
Creatine kinase-myocardial (CK-MB) band is represented in µg/L. If the value of CK-MB exceeds 6.2 µg/L, then CK-MB is able to detect myocardial ischemia at the predefined time points.
Time Frame
Until 24 hours after clamping the aorta
Title
The influence of continued mechanical ventilation on the release of heart-type fatty acid-binding protein (hFABP)
Description
Heart-type fatty acid-binding protein (hFABP) is represented in ng/L. If the value of hFABP exceeds 6 ng/L, then hFABP is able to detect myocardial ischemia at the predefined time points.
Time Frame
Until 5 hours after clamping the aorta
Title
The influence of continued mechanical ventilation on lipid peroxidation
Description
Lipid peroxidation is measured using the malondialdehyde assay.
Time Frame
Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
Title
The influence of continued mechanical ventilation on the redox balance
Description
superoxide dismutase 1 and 2 (SOD1, SOD2), nuclear factor erythroid 2-related factor 2 (Nrf2), catalase (CAT), glutathione peroxidase (GPx), NADPH oxidase 2 and 4 (NOX2, NOX4), heme oxygenase-1 (HO-1), NAD(P)H quinone oxidoreductase 1 (NQO-1)) will be studied to determine the redox balance.
Time Frame
Until unclamping the aorta (on average until 64 minutes after clamping the aorta) ]
Title
The influence of continued mechanical ventilation on the partial pressure of oxygen (pO2)
Description
pO2 is represented in mmHg. If pO2 is lower than 60 mmHg, then hypoxemia is present.
Time Frame
Until the end of surgery (on average until 203 minutes after the start of the surgery)
Title
The influence of continued mechanical ventilation on the partial pressure of carbon dioxide (pCO2)
Description
pCO2 is represented in mmHg.
Time Frame
Until the end of surgery (on average until 203 minutes after the start of the surgery)
Title
The influence of continued mechanical ventilation on the pH
Description
The pH will measure the acidity.
Time Frame
Until the end of surgery (on average until 203 minutes after the start of the surgery)
Title
The influence of continued mechanical ventilation on lactate
Description
Lactate is represented in mmol/L.
Time Frame
Until the end of surgery (on average until 203 minutes after the start of the surgery)
Secondary Outcome Measure Information:
Title
The occurence of myocardial infarction
Description
This is based on the Fourth universal definition of myocardial infarction (2018).
Time Frame
Until 30 days after surgery
Title
The occurence of mortality
Description
All-cause mortality is evaluated.
Time Frame
Until 30 days after surgery
Title
The occurence of neurological complications
Description
Neurological complications include cerebrovascular accident (CVA), transient ischemic attack (TIA), delirium, epilepsy
Time Frame
Until 30 days after surgery
Title
The occurence of graft failure
Description
Graft failure describes total graft occlusion that prevents blood flow through the graft to the revascularized part of the heart.
Time Frame
Until 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Kaya, MD, PhD
Phone
011 33 71 05
Email
Abdullah.kaya@jessazh.be
First Name & Middle Initial & Last Name or Official Title & Degree
Jade Claessens, MSc
Phone
011 33 71 07
Email
jade.claessens@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah Kaya, MD, PhD
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Kaya, MD, PhD
Phone
+3211337105
Email
abdullah.kaya@jessazh.be

12. IPD Sharing Statement

Plan to Share IPD
No

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

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