Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,000
- 试验地点
- 2
- 主要终点
- INCIDENCE of PERIOPERATIVE COMPLICATIONS
研究概览
简要总结
The hypothesis is that patients undergoing cardiac catheterization, in which the New Safety Checklist has been used, have fewer perioperative complications compared to patients in which the habitual practice has been used.
详细描述
The aim of this study is to develop a New Safety Checklist in perioperative patients undergoing cardiac catheterization in interventional cardiology units and assess it impact on the incidence of perioperative complications compared to habitual practice.
The study will consist in two phases; the first phase: development of the New Safety Checklist, and the second phase will be a multicenter randomized clinical trial, a parallel two-arm corresponding to the use of the New Safety Checklist compared to the habitual practice in all patients undergoing cardiac catheterization in interventional cardiology units, according to the inclusion criteria..
The expected number of patients in this trial will be 6000. The principal outcome of this study will be: the incidence of perioperative complications. The secondary outcomes will be: socio-demographic data, clinical patient data and procedure type data. Data collection will be done through reviewing clinical history.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Adult patients (>18 years) undergoing cardiological intervention in hemodynamic units and interventionist cardiology.
- •Patients who accept to participate in the study.
排除标准
- •Patients undergoing urgent procedure.
- •Patients requiring ventilatory support or in a situation of hemodynamic instability.
- •Patients with cognitive impairment, mental disability or other serious difficulty in communication.
- •Patients with insufficient fluidity of the main languages.
结局指标
主要结局
INCIDENCE of PERIOPERATIVE COMPLICATIONS
时间窗: from the discharge or up to 24 hours post-procedure
The perioperative complications will be collected after randomization, from discharge or up to24 hours post-procedure. The clinical history will be reviewed to evaluate the incidence of complications. Expected complications will be: severe systemic complications (major cardiovascular events \[MACE\], coronary artery complications, and structural complications), peripheral vascular complications, and reactions to contrast media.
次要结局
- Procedure data(from the discharge or up to 24 hours post-procedure)
- Socio-demographic data(from the discharge or up to 24 hours post-procedure)
- Clinical data(from the discharge or up to 24 hours post-procedure)