The Utility of Novel Measurements of Diastolic Function Involving Transoesophageal and Transthoracic Echocardiography in the Peri-operative Period in Patients Undergoing Cardiac Surgery -an Exploratory Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Change in diastolic dysfunction -categorised as improved, stable or worse
研究概览
简要总结
This observational clinical trial will investigate the following perioperative indices relating to cardiac surgery:
- The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
- The significance of measurements involving right heart relaxation function and itrs relation to outcome measures.
- The influence of drugs such as enoximone on these outcome measures.
详细描述
Over the past two decades, perioperative TOE has become routine part of monitoring in the setting of cardiac surgery. In many centres around the world nearly 100% of pateints undergoing cardiac surgery are monitored using this modality. There are several studies and observational reviews suggesting intraoperative TOE can change management and thus indirectly influence outcome in patients undergoing valve, aortic or bypass graft surgery. Certainly in our centre at The Heart Hospital, it is routine practce to perform an intraoperative TOE in all patients undergoing cardiac surgery in order to guide surgical and anaesthetic management of the patient. Despite this use of TOE there is very little evidence of how TOE influences patient related outcomes, both morbidity and mortality.
Several advances have occurred over the years involving both better technology to image the heart with TOE along with the development of novel measurements of heart function. As technology has evolved, many modalities and measurement have not been validated in the setting of cardiac surgery. In our observational clincal trial we aim to investigate the following:
- The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
- The significance of measurements involving the right heart relaxation function and itrs relation to outcome measures.
- The influence of drugs such as enoximone on these outcome measures.
While many of these measurements have been validated in the care of medical patients, they have not been examined in the surgical setting. In addition, its ability to predict outcome has never been tested. We believe this study will help us answer these important questions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Systolic dysfunction (EF <50%) or diastolic dysfunction grade 1-3 as determined through preoperative TTE or intraoperative TOE
- •Able to give informed consent
排除标准
- •Contraindication to transoesphageal echocardiography (such as previous oesophagectomy)
结局指标
主要结局
Change in diastolic dysfunction -categorised as improved, stable or worse
时间窗: Up to 12 hours
Compare diastolic dysfunction before and after surgery in those that receive enoximone. Compare diastolic function before and after surgery in those that do not receive enoximone
次要结局
- Duration of endotracheal intubation (in hours)(0-30 days)
- Duration of ICU stay(0-30 days)
- Cardiac Post Operatie Morbidity Score (C-POMS)(0-30 days)
- 30 day Major Adverse Cardiovascular Events(0-30 days)
- Incidence of post operative atrial fibrillation(0-30 days)
- Systolic and diastolic data from the post operative transthoracic echocardiogram(Up to 30 days)
- Duration of hospital stay(0-30 days)