Myocardial Strain Analysis in Patients With Coronary Artery Disease at Hyperoxia and Normoxaemia Prior to Coronary Artery Bypass Graft Surgery - a Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Difference in myocardial peak strain between oxygen levels
研究概览
简要总结
The purpose of this study is to investigate the impact of supraphysiologic oxygen (hyperoxia) on myocardial function in anaesthetized patients with coronary artery disease.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
TEE images will be coded and analysed in batches at a later date by a blinded reader
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective CABG surgery (with or without other cardiac surgery)
- •Ability to give and sign informed consent
- •Age >18 years.
排除标准
- •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
研究组 & 干预措施
Normoxaemia First
Patients will undergo TEE imaging at normoxaemia (FiO2=0.3) first, and hyperoxia (FiO2=0.8) will be targeted second.
干预措施: Oxygen (Drug)
Hyperoxia First
Patients will undergo TEE imaging at hyperoxia (FiO2=0.8) first, and normoxaemia (FiO2=0.3) will be targeted second.
干预措施: Oxygen (Drug)
结局指标
主要结局
Difference in myocardial peak strain between oxygen levels
时间窗: Through study completion, within 1hour post-induction
Percent (%), a measure of systolic function (shortening and thickening) of the myocardium
次要结局
- Difference in peak twist(Through study completion, within 1hour post-induction)
- Difference in peak torsion(Through study completion, within 1hour post-induction)
- Difference in myocardial strain rate ratio between oxygen levels(Through study completion, within 1hour post-induction)
- Difference in myocardial time to peak strain between oxygen levels(Through study completion, within 1hour post-induction)
- Difference in myocardial strain rate between oxygen levels(Through study completion, within 1hour post-induction)
- Difference in myocardial displacement between oxygen levels(Through study completion, within 1hour post-induction)
- Difference in myocardial time to peak displacement between oxygen levels(Through study completion, within 1hour post-induction)
- Difference in myocardial velocities between oxygen levels(Through study completion, within 1hour post-induction)
- Difference in myocardial velocity ratio between oxygen levels(Through study completion, within 1hour post-induction)
- Difference in ejection fraction (EF)(Through study completion, within 1hour post-induction)
- Difference in chamber volumes(Through study completion, within 1hour post-induction)