Clinical trial NCT05109715: The Effect of Mechanical Ventilation on the Occurrence of Myocardial Ischemia: a Pilot Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Hypoxia
Keywords: Cardiac surgery
Ventilation
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The detection of myocardial ischemia using Cardiac Troponin T (cTn-T)
timeFrame: Until 72 hours after clamping the aorta
measure: The detection of myocardial ischemia using Heart-type Fatty Acid Binding Protein (hFABP)
timeFrame: Until 5 hours after clamping the aorta
measure: The detection of myocardial ischemia using Creatine Kinase Myocardial Band (CK-MB)
timeFrame: Until 48 hours after clamping the aorta
measure: The detection of myocardial ischemia using Reactive Oxygen Species (ROS)
timeFrame: Until unclamping the aorta (on average until 64 minutes after clamping the aorta)
measure: The occurence of hypoxemia using blood gas measurement
timeFrame: Until the end of surgery (on average until 203 minutes after the start of the surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Abdullah Kaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: