Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mean total fluoroscopy radiation time (expressed in seconds)
研究概览
简要总结
The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes.
The main questions it aims to answer are:
- Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision?
- Will major and minor procedural complications be reduced after simulator-based training?
Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period.
They will be supervised during their cath lab period as first operators by senior interventional cardiologists.
During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Specializing doctors who are about to start dedicated training in the interventional cardiology room
- •Patients who must undergo coronary angiography examination.
排除标准
- •Specializing doctors:
- •No interest in performing interventional cardiology procedures as first supervised operator (classical training)
- •Experience as first supervised operator in interventional cardiology procedures
- •Absence of informed consent
- •Acute Coronary Syndrome
- •Severe left ventricular dysfunction with ejection fraction less than 30%
- •Severe chronic renal failure (with glomerular filtration rate less than 30 ml/min)
- •Absence of informed consent
研究组 & 干预措施
Simulator-based training group
Interventional cardiology fellows will undergo a two-day training program on high-fidelity simulators
干预措施: Simulator-based training (Procedure)
Standard group
Interventional cardiology fellows will undergo standard training based on master-apprentice model
干预措施: Standard training (Procedure)
结局指标
主要结局
Mean total fluoroscopy radiation time (expressed in seconds)
时间窗: End of procedure
Difference in Mean total fluoroscopy radiation time, during the periods where the cardiology fellows act as primary operators, between groups
次要结局
- Number of catheters used(End of procedure)
- Total contrast dose (expressed in ml)(End of procedure)
- Mean arterial cannulation time (expressed in seconds)(End of procedure)
- Total radiation dose (expressed in cGy*cm2)(End of procedure)
- Any major or minor procedural and clinical complication(Up to the end of index hospitalization or date of death from any cause (we collect any kind of clinical or procedural complication occuring during the determined period))
- Failure to achieve arterial cannulation (e.g.: rate of failure for each partecipant)(End of procedure)
- Failure to achieve left coronary cannulation (e.g.: rate of failure for each partecipant)(End of procedure)
- Failure to achieve right coronary cannulation (e.g.: rate of failure for each partecipant)(End of procedure)
研究者
Burzotta Francesco
Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS