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

NCT05417217 | Terminated

• 1 other identifier: f/2022/096
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Hypoxia

Keywords

Cardiac surgery; Minimally invasive cardiac surgery; Endoscopic coronary artery bypass grafting; Harlequin syndrome; Ventilation

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  Until 5 hours after clamping the aorta

• The influence of continued mechanical ventilation on lipid peroxidation

  Lipid peroxidation is measured using the malondialdehyde assay.

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (4)

• The occurence of myocardial infarction

  Until 30 days after surgery

• The occurence of mortality

  Until 30 days after surgery

• The occurence of neurological complications

  Until 30 days after surgery

• The occurence of graft failure

  Until 30 days after surgery

Study Arms (2)

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

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

Procedure: Continued ventilation

Interventions

Discontinued ventilation PROCEDURE

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

Control group

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.

Ventilation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Belgium

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Hypoxia; Harlequin syndrome; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Alaaddin Yilmaz, MD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: October 17, 2022
• Primary Completion: November 9, 2024
• Study Completion: November 9, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)