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Myocardial Strain Analysis in Anaesthetized Coronary Artery Disease Patients During Hyperoxia and Normoxaemia

Not Applicable
Completed
Conditions
Coronary Artery Disease
Anesthesia
Interventions
Registration Number
NCT04424433
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Brief Summary

The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.

Detailed Description

Up to 106 patients with coronary artery disease undergoing elective coronary artery bypass graft (CABG) surgery will be recruited to undergo this single visit study. In the timeframe shortly after the induction of anaesthesia and prior to the start of surgery, myocardial strain as a marker of cardiac function will be measured by transesophageal echocardiography (TEE). Echocardiography measurements will be acquired at two different oxygen states for each patient. The fraction of inspired oxygen (FiO2) will be adjusted to reach a normoxaemic state (FiO2=0.3) and a hyperoxic state (FiO2=0.8). Patients will be randomized to which oxygen level is investigated first. Thereafter, the study intervention is completed and anaesthesia and surgery will be performed as planned by the treating team. Echocardiography images will be analyzed in a blinded manner for cardiac function and systolic and diastolic strain parameters. The results will help anaesthesiologists to better weigh risks and benefits when selecting an inspired oxygen fraction in such patients, and will help to evaluate hyperoxia as a risk factor for myocardial injury.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
106
Inclusion Criteria
  • Elective CABG surgery (with or without other cardiac surgery)
  • Ability to give and sign informed consent
  • Age >18 years.
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Exclusion Criteria
  • Absolute contraindication for TEE
  • Emergency surgery, including but not limited to patients with instable CAD: ST- and Non-ST-elevation myocardial infarction (STEMI, NSTEMI) and instable angina (instable AP)
  • Atrial fibrillation or significant arrhythmia
  • Pacemaker, CRT, left bundle branch block
  • Severe-grade valvular disease
  • Pericardial disease
  • Previous cardiac or thoracic aortic surgery
  • Previous chest radiation therapy or cardiotoxic or bleomycin chemotherapy
  • Severe pulmonary hypertension, cor-pulmonale, or right ventricular dysfunction, i.e., where high FIO2 might reduce pulmonary vascular resistance and right ventricular afterload
  • Patients where study explanation and informed consent cannot been performed/obtained at the latest on the day before scheduled surgery
  • Females of child-bearing potential
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Normoxaemia FirstOxygenPatients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second.
Hyperoxia FirstOxygenPatients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second.
Primary Outcome Measures
NameTimeMethod
Difference in myocardial peak strain between oxygen levelsThrough study completion, within 1hour post-induction

Percent (%), a measure of systolic function (shortening and thickening) of the myocardium

Secondary Outcome Measures
NameTimeMethod
Difference in peak twistThrough study completion, within 1hour post-induction

Degrees (°)

Difference in peak torsionThrough study completion, within 1hour post-induction

Degrees/centimeter (°/cm)

Difference in myocardial time to peak strain between oxygen levelsThrough study completion, within 1hour post-induction

Milliseconds (ms)

Difference in myocardial strain rate between oxygen levelsThrough study completion, within 1hour post-induction

Change in strain over time (/second)

Difference in myocardial strain rate ratio between oxygen levelsThrough study completion, within 1hour post-induction

Change in E/A ratio

Difference in myocardial displacement between oxygen levelsThrough study completion, within 1hour post-induction

Millimeters (mm)

Difference in myocardial time to peak displacement between oxygen levelsThrough study completion, within 1hour post-induction

Milliseconds (ms)

Difference in myocardial velocities between oxygen levelsThrough study completion, within 1hour post-induction

Change in displacement over time (millimeters/second)

Difference in myocardial velocity ratio between oxygen levelsThrough study completion, within 1hour post-induction

Change in E/A ratio

Difference in ejection fraction (EF)Through study completion, within 1hour post-induction

Percent (%)

Difference in chamber volumesThrough study completion, within 1hour post-induction

Millilitres (ml)

Trial Locations

Locations (1)

Bern University Hospital, Inselspital

🇨🇭

Bern, Switzerland

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