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

  • STATUS
    Recruiting
  • End date
    Feb 24, 2024
  • participants needed
    106
  • sponsor
    University Hospital Inselspital, Berne
Updated on 24 January 2021
coronary artery disease
bypass graft
heart surgery
cardiac operation
arterial disease

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.

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.

Details
Condition Coronary Artery Disease, Coronary heart disease, dental anesthesia, Anesthesia, Anesthesia (Local), Cardiac Ischemia, Myocardial Ischemia, sensory loss, anaesthesia, anesthesia for, anesthesia procedures
Treatment Oxygen
Clinical Study IdentifierNCT04424433
SponsorUniversity Hospital Inselspital, Berne
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Anesthesia or Coronary heart disease or Coronary Artery Disease or Anesthesia (Local)?
Do you have any of these conditions: Anesthesia (Local) or Coronary heart disease or anesthesia procedures or Anesthesia or anesthesia for or dental anesthesia or Coronary Artery Disease ...?
Elective CABG surgery (with or without other cardiac surgery)
Ability to give and sign informed consent
Age >18 years

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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