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

Primary Purpose

Myocardial Ischemia, Hypoxia

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

About this trial

This is an interventional treatment trial for Myocardial Ischemia focused on measuring Cardiac surgery, Ventilation

Eligibility Criteria

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

Sites / Locations

  • Jessa Hospital

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 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

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

Outcomes

Primary Outcome Measures

The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)
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.
The detection of myocardial ischemia using Heart-type Fatty Acid Binding Protein (hFABP)
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.
The detection of myocardial ischemia using Creatine Kinase Myocardial Band (CK-MB)
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.
The detection of myocardial ischemia using Reactive Oxygen Species (ROS)
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.
The occurence of hypoxemia using blood gas measurement
If the partial pressure of oxygen (PaO2) is lower than 60 mmHg, then hypoxemia is present.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2021
Last Updated
October 20, 2022
Sponsor
Jessa Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05109715
Brief Title
The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia: a Pilot Study
Acronym
VENTMICS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
October 4, 2022 (Actual)

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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Hypoxia
Keywords
Cardiac surgery, Ventilation

7. Study Design

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

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 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
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 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
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.
Intervention Type
Procedure
Intervention Name(s)
Discontinued ventilation
Intervention Description
Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure
Primary Outcome Measure Information:
Title
The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)
Description
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.
Time Frame
Until 72 hours after clamping the aorta
Title
The detection of myocardial ischemia using Heart-type Fatty Acid Binding Protein (hFABP)
Description
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.
Time Frame
Until 5 hours after clamping the aorta
Title
The detection of myocardial ischemia using Creatine Kinase Myocardial Band (CK-MB)
Description
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.
Time Frame
Until 48 hours after clamping the aorta
Title
The detection of myocardial ischemia using Reactive Oxygen Species (ROS)
Description
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.
Time Frame
Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
Title
The occurence of hypoxemia using blood gas measurement
Description
If the partial pressure of oxygen (PaO2) 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah Kaya, PhD
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
State/Province
Limburg
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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