Cardiac Surgery Residents' Learning Curve of Intraoperative Transit-time Flowmetry and High-frequency Ultrasound in Coronary Artery Bypass Surgery: the LEARNERS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of anastomoses needed to reach a ratio (total score/n. of anastomoses) >= 11
研究概览
简要总结
Transit-time flowmetry (TTFM) allows grafts quality assessment during coronary artery bypass surgery by measuring the flow volume through them. Recently the intraoperative epicardial high-frequency ultrasound (HFUS) was introduced, with the possibility of capturing bidimensional images of the anastomoses. When combined, these two techniques provide high diagnostic yield reaching a positive predictive value of 100 percent.
Despite current guidelines recommend the employment of TTFM and HFUS, they remain largely underused probably because of limited information and the lack of standardization. Furthermore, surgeons must overcome a learning curve to handle both techniques properly, but few data are available according the current literature.
The main purpose of this study is to evaluate the complexity of HFUS and TTFM learning curve. This is a prospective, observational, monocentric cohort study. Adult patients undergoing coronary artery bypass surgery will be enrolled.
详细描述
This is a prospective, observational, monocentric cohort study in which adult patients undergoing coronary artery bypass surgery will be enrolled.
Primary objective of this study is to evaluate the complexity of cardiac surgery residents' learning curve for grafts quality assessment with transit-time flowmetry (TTFM) and intraoperative epicardial high-frequency ultrasound (HFUS).
Secondary objectives are to evaluate the complexity of cardiac surgery residents' learning curve for grafts quality assessment with TTFM and HFUS as isolated techniques.
The study will last four months (three months for patients enrollment and data collection and one month for statistical analysis and scientific paper writing).
The trial will start after obtaining favourable opinion from the local Ethics Committee and could be considered completed when all the eight cardiac surgery residents involved have reached primary endpoint.
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
- •Age >= 18 years old;
- •Written informed consent;
- •Indication to CABG surgery (both "on-pump" and "off-pump");
- •Stable angina, unstable angina or acute coronary syndrome without ST elevation (NSTEMI).
排除标准
- •Age >= 18 years old;
- •Written informed consent;
- •Indication to CABG surgery (both "on-pump" and "off-pump");
- •Stable angina, unstable angina or acute coronary syndrome without ST elevation (NSTEMI).
结局指标
主要结局
Number of anastomoses needed to reach a ratio (total score/n. of anastomoses) >= 11
时间窗: This evaluation will require from 1 to 3 months.
Number of anastomoses needed to reach a ratio between total score and the number of studied anastomoses of 11 or more
次要结局
- Number of anastomoses needed to reach a ratio (HFUS score/n. of anastomoses) = 4(This evaluation will require from 1 to 3 months.)
- Number of anastomoses needed to reach a ratio (TTFM score/n. of anastomoses) >=7(This evaluation will require from 1 to 3 months.)
研究者
Federico Cammertoni
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS