Evaluation of the Clinical Impact of Ultra Fast-Track in Patients Undergoing Cardiac Surgery Versus Conventional Extubation (CARDU-FAST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 612
- 试验地点
- 2
- 主要终点
- Determine the effect of Ultra Fast-track
研究概览
简要总结
Single center randomized clinical trial. The main aim is to demonstrate the superiority at the clinical level of the ultra fast-track programs versus conventional early postoperative extubation in patients undergoing cardiac surgery.
详细描述
The study is aimed to compare clinical superiority of ultra fast-track versus conventional early postoperative extubation in patients undergoing cardiac surgery in our center. The estimated sample size is 612 patients. They will be randomized 1:1 to any of the two arms of the study (ultra fast-track vs. fast-track). The randomization will be stratified according the type of surgery performed. The period of recruitment will start in January 2023 and is supposed to finish by September 2024 or earlier. The main outcomes of the study will be measured 1 year after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double
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
- •Patients over 18 years of age.
- •Patients with valvular, coronary or aortic heart disease with an indication for major cardiac surgery.
- •The patient's desire to participate in the clinical trial verified by signing the informed consent.
排除标准
- •Emergent surgery or cardiorespiratory arrest.
- •Patient in preoperative cardiogenic shock, or in need of high-dose vasoactive support.
- •Aortic arch procedures.
- •Procedures in which hypothermia < 28ºC of temperature is expected during the intervention.
- •Minor cardiac surgery procedures.
- •Procedures with minimally invasive techniques without extracorporeal circulation (Transcatheter aortic valve implantation, Transcatheter mitral valve implantation, Minimally invasive mitral valve repair (TOP-Mini), Totally thoracoscopic MAZE procedure, Minimally invasive direct coronary artery bypass grafting).
- •Implantation of circulatory assistance devices or ECMO (extracorporeal membrane oxygenation).
- •Active endocarditis.
结局指标
主要结局
Determine the effect of Ultra Fast-track
时间窗: 1 year
Determine the effect of Ultra Fast-track on the occurrence of the composite outcome composed of all-cause mortality, respiratory complications (prolonged intubation over 24h, reintubation, or pneumonia) and AKIN-III (acute renal failure) in patients undergoing ultra fast-track and patients with conventional postoperative extubation.
次要结局
- Differences in the incidence of heart reoperation(1 year)
- Procedural resources conpsumption(1 year)
- Differences in the need for high flow nasal oxygen therapy or non-invasive ventilation for >24h.(1 year)
- Differences in the incidence of acute myocardial infarction.(1 year)
- Differences in major bleeding or life-threatening bleeding.(1 year)
- Differences in the incidence of infections rate.(1 year)
- Differences in neurological complication(1 year)
研究者
Lourdes Montero Cruces
Cardiovascular Surgeon
Hospital San Carlos, Madrid