Timing for Removal of Chest Tubes in Adult Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 515
- 试验地点
- 2
- 主要终点
- Rate of postoperative pleural and/or pericardial effusion
研究概览
简要总结
Rationale:
Evidence regarding the timing of chest tube removal after cardiac surgery is sparse. The timing of chest tubes removal constitutes a balancing act between risk of retained blood syndrome, infection, patient discomfort and opioid-related side effects. Several studies have shown that chest tubes can safely be removed on the first postoperative day compared to later. A single retrospective study raised concern as chest tube removal on the day of surgery was associated with an increased requirement of drainage of pleural effusions.
Primary Objective:
To compare the impact of two standard chest tube removal protocols following open-heart surgery on the incidence of pleural and/or pericardial effusion requiring invasive drainage
Secondary Objectives
To evaluate the impact of chest tube removal on the day of surgery (DAY0) compared to the first postoperative day (DAY1) regarding:
- Comsumption of analgetic drugs
- Early postoperative pain
- Incidence of infection
- Early postoperative respiratory function
Study design:
Single-center, open, parallel-group, prospective, cluster-randomized controlled trial Alternate assignment of chest tube removal according to Day 0 versus Day 1 protocol based upon the month of surgery (even versus odd months).
Study population:
1300 consecutive patients undergoing elective open heart surgery in full or lower hemisternotomy with or without cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, simple aortic surgery or combinations.
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
- •All consecutive patients undergoing elective open heart surgery in full or lower hemisternotomy with or without cardiopulmonary bypass including coronary artery bypass grafting, valve surgery, simple aortic surgery or combinations.
排除标准
- •Cardiac procedures deemed not eligible to chest tube removal on the day of surgery due to increased bleeding risk due to:
- •Procedures in hypothermic circulatory arrest
- •Previous cardiac surgery
- •Procedures performed through upper hemisternotomy
- •Emergent treatment required (< 24 hours)
- •Non-aspirin antiplatelet drugs stopped < 5 days preoperatively (Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine)
- •Current use of vitamin K antagonists or new oral non-vitamin K anticoagulants
- •Platelet count > 450 or <100 x 109/l prior to surgery
结局指标
主要结局
Rate of postoperative pleural and/or pericardial effusion
时间窗: up to 30 days after surgery
Effusion requiring invasive drainage
次要结局
- Rate re-exploration because of bleeding(up to 30-day follow-up)
- Time until chest tube removal(In-hospital)
- Length of stay on cardiac surgery intensive care unit(In-hospital)
- Duration of mechanical ventilation(In-hospital (max up to 30 days))
- Intensity of postoperative pain(Before and after first mobilization day 1)
- Amount of chest tube output(after 24 hours and up to removal (max. up to 30 days))
- Re-hospitalization due to pleural or pericardial effusion up to 30-day follow-up(up to 30-day follow-up)
- Rate of acute kidney injury(up to 30-day follow-up)
- Rate of infection requiring antibiotic treatment:(up to 30-day follow-up)
- Quantity of opiod consumption(During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days)
- Quantity of non-steroidal anti-inflammatory drug consumption(During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days)
- Number of re-exploration due to tamponade(up to 30-day follow-up)
- Length of hospital stay after surgery(up to 30-day follow-up)
- Rate of new-onset atrial fibrillation(up to 30-day follow-up)
- Early postoperative respiratory function(after first mobilization day 1)
- Need for supplemental oxygen(In-hospital (max up to 30 days))
研究者
Ivy susanne Modrau, MD
Consultant Cardiac Surgeon, Associate Professor
Aarhus University Hospital Skejby