Cardiovascular DiseasesVENTMICS-IINCT05417217
The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia
A study testing Discontinued ventilation and Continued ventilation in people with Cardiovascular Diseases and Coronary Artery Disease, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- Discontinued ventilation and Continued ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Oct 2022to 9 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Totally Endoscopic Coronary Artery Bypass Grafting
The goal of this study is to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.
Read the 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.
- Being tested
- Discontinued ventilation, Continued ventilation
- Keywords
- Cardiac surgery, Minimally invasive cardiac surgery, Endoscopic coronary artery bypass grafting, Harlequin syndrome, Ventilation
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Hypoxia, Harlequin syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinued ventilationProcedure or surgery
Ventilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure
Continued ventilationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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 Receives: Procedure: Discontinued ventilation |
| Ventilation group | Experimental | 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 Receives: Procedure: Continued ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until 24 hours after clamping the aorta
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.
Measured: Until 24 hours after clamping the aorta
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.
Measured: Until 5 hours after clamping the aorta
The influence of continued mechanical ventilation on lipid peroxidation
Lipid peroxidation is measured using the malondialdehyde assay.
Measured: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
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.
Measured: Until unclamping the aorta (on average until 64 minutes after clamping the aorta) ]
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.
Measured: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The influence of continued mechanical ventilation on the partial pressure of carbon dioxide (pCO2)
pCO2 is represented in mmHg.
Measured: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The influence of continued mechanical ventilation on the pH
The pH will measure the acidity.
Measured: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The influence of continued mechanical ventilation on lactate
Lactate is represented in mmol/L.
Measured: Until the end of surgery (on average until 203 minutes after the start of the surgery)
Secondary outcomes (4)
The occurence of myocardial infarction
This is based on the Fourth universal definition of myocardial infarction (2018).
Measured: Until 30 days after surgery
The occurence of mortality
All-cause mortality is evaluated.
Measured: Until 30 days after surgery
The occurence of neurological complications
Neurological complications include cerebrovascular accident (CVA), transient ischemic attack (TIA), delirium, epilepsy
Measured: Until 30 days after surgery
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.
Measured: Until 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start17 Oct 2022
- Primary completion9 Nov 2024
- Study completion9 Nov 2024
Why it stopped: After the passing of the principal investigator, the clinical trial could not be continued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alaaddin Yilmaz, MD, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417217
- Sponsor's protocol ID
- f/2022/096
- Acronym
- VENTMICS-II
- Status last verified
- Jan 2024
- First submitted
- 9 Jun 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia in Patients Undergoing Totally Endoscopic Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT05417217
- Acronym / sponsor ID
- VENTMICS-II / f/2022/096
- Keywords
- Cardiac surgery, Minimally invasive cardiac surgery, Endoscopic coronary artery bypass grafting, Harlequin syndrome, Ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After the passing of the principal investigator, the clinical trial could not be continued.
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- 9 Nov 2024 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Discontinued ventilationVentilation 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 group | Experimental | Procedure: Continued ventilationVentilation 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinued ventilationVentilation is discontinued after going on CPB and lungs are exposed to atmospheric pressure | Procedure or surgery | Control group |
| Continued ventilationVentilation 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. | Procedure or surgery | Ventilation group |
Primary outcome
The influence of continued mechanical ventilation on the release of cardiac troponin T (cTn-T)
Time frame: Until 24 hours after clamping the aorta
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)
Time frame: Until 24 hours after clamping the aorta
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)
Time frame: Until 5 hours after clamping the aorta
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
Time frame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
Lipid peroxidation is measured using the malondialdehyde assay.
The influence of continued mechanical ventilation on the redox balance
Time frame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta) ]
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)
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
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)
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
pCO2 is represented in mmHg.
The influence of continued mechanical ventilation on the pH
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
The pH will measure the acidity.
The influence of continued mechanical ventilation on lactate
Time frame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
Lactate is represented in mmol/L.
4 secondary outcomes
The occurence of myocardial infarction
Time frame: Until 30 days after surgery
The occurence of mortality
Time frame: Until 30 days after surgery
The occurence of neurological complications
Time frame: Until 30 days after surgery
The occurence of graft failure
Time frame: Until 30 days after surgery
Results and safety
The study was stopped early (reason given: After the passing of the principal investigator, the clinical trial could not be continued.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaaddin Yilmaz, MD principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinued ventilation and Continued ventilation in people with Cardiovascular Diseases and Coronary Artery Disease, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After the passing of the principal investigator, the clinical trial could not be continued.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of continued mechanical ventilation on the release of cardiac troponin T (cTn-T) (time frame: Until 24 hours after clamping the aorta). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.