Default vs As-Needed Intraoperative Transesophageal Echocardiography (TEE) in Low-Risk Isolated Coronary Artery Bypass Graft (CABG) Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Primary Objectives
研究概览
简要总结
This goal of this study is to better understand when and where intraoperative transesophageal echocardiography (TEE) should (or should not) be used during coronary artery bypass graft (CABG) surgeries.
详细描述
This trial will look at benefits and harms to two different treatments strategies in order to improve clinical outcomes. Intraoperative TEE is an ultrasound-based, imaging device that uses sound waves to look at the heart continuously during a heart surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo isolated CABG surgery at a hospital within the UPenn Health System
- •Age ≥18 years
- •Ejection fraction ≥50%
- •Transthoracic echocardiography within one year of scheduled surgery date
- •Left heart catheterization within one year of scheduled surgery date
- •English language fluency or facilitated via language interpreter
- •Able to provide informed consent either in English or via a language interpreter
- •Willing to comply with all study procedures
排除标准
- •Documented valve (aortic, mitral, tricuspid, or pulmonic) disease (stenosis or regurgitation) moderate or greater.
- •Any CABG surgery with either "possible" or "definite" aortic intervention listed as a planned part of the procedure. plan for either definite or possible surgical intervention.
- •Any CABG surgery with either "possible" or "definite" valve repair/replacement listed as a planned part of the procedure.
- •Having undergone any previous cardiac surgeries (i.e. scheduled with a "REDO" modifier).
- •Proximal/critical left main coronary disease (e.g. greater than or equal to 90% stenosis).
- •Preexisting anomalous coronary arteries
- •Preexisting end-stage renal disease on hemodialysis
- •Preexisting chronic kidney disease (CKD) stage 3, 4, or 5
- •Stroke with residual focal neurological deficit(s) within 90 days of surgery
- •Any of the following presurgical, mechanical circulatory support devices:
- •Intraaortic balloon pump
- •Percutaneous right ventricular assist device (RVAD)
- •Extracorporeal membrane oxygenation (ECMO)
- •Absolute contraindication to echocardiography defined as one or more of the following documented conditions:
- •Esophagectomy
- •Esophagogastrectomy
- •Esophageal trauma
- •Any of these three relative contraindication to TEE:
- •Esophageal varies
- •Gastric bypass surgery
- •Descending thoracic aortic aneurysm
- •Severe pulmonary hypertension defined as:
- •Pulmonary arterial pressure ≥60 mmHg
- •Pulmonary vascular resistance (PVR) ≥3 Woods Units
- •Hemodynamic instability after induction and following placement of an endotracheal tube will be defined as one or more of the following events or scenarios:
- •Placement of an intraaortic balloon pump (IABP)
- •Initiation of venoarterial extracorporeal membrane oxygenation (VAECMO)
- •Placement of a right or left percutaneous mechanical circulatory support device
- •Initiation of epinephrine infusion at a dose ≥ 6 mcg/min for a duration ≥5 minutes
- •Initiation of norepinephrine at a dose ≥8 mcg/min for a duration ≥ minutes
- •Initiation of phenylephrine infusion at a dose ≥100 mcg/min for a duration ≥ minutes
- •Initiation of vasopressin infusion at a dose ≥0.04 units/min for a duration ≥ minutes
研究组 & 干预措施
As-needed TEE
The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.
干预措施: TEE probe (Device)
Default TEE
The TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of the heart before and after a CABG surgery. If randomized to this group, the TEE probe will remain in place throughout the surgery.
干预措施: TEE probe (Device)
结局指标
主要结局
Primary Objectives
时间窗: 24 months
1. Recruitment feasibility assessment as measured by an absolute recruitment rate. Absolute recruitment rate is defined as the number of successfully enrolled participants divided by the total number of screened participants. 2. Assess intervention fidelity by calculating the rate of TEE performed among participants randomized to the as-needed TEE trial arm.
次要结局
- Secondary Objectives(24 month)