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

NCT05109715 | Completed

• 1 other identifier: f/2021/118
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia; Hypoxia

Keywords

Cardiac surgery; Ventilation

Outcome Measures

Primary Outcomes (5)

• 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.

  Until 72 hours after clamping the aorta

• 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.

  Until 5 hours after clamping the aorta

• 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.

  Until 48 hours after clamping the aorta

• 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.

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

• The occurence of hypoxemia using blood gas measurement

  If the partial pressure of oxygen (PaO2) 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)

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 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

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 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

Procedure: Continued ventilation

Interventions

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

Discontinued ventilation PROCEDURE

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

Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Ongoing participation in another trial
• Ejection fraction \< 50%
• Lung diseases (COPD, asthma)
• Use of corticosteroids

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, Belgium

Location

MeSH Terms

Conditions

Myocardial Ischemia; Hypoxia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Study Officials

• Abdullah Kaya, PhD

  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: October 27, 2021
• First Posted: November 5, 2021
• Study Start: January 24, 2022
• Primary Completion: April 18, 2022
• Study Completion: October 4, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)