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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
515
Elective open heart surgery
Dep. of Cardiothoracic Surgery, Aarhus University Hospital
Aarhus, Denmark
Rate of postoperative pleural and/or pericardial effusion
Effusion requiring invasive drainage
Time frame: up to 30 days after surgery
Quantity of opiod consumption
Measured as oral morphine equivalent daily dose (mg/day)
Time frame: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
Quantity of non-steroidal anti-inflammatory drug consumption
Daily dose of NSAIDs standardized by using the manufacturers' recommended minimum daily maintenance doses for rheumatoid arthritis as 1 dose unit
Time frame: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
Intensity of postoperative pain
Measured as NRS score: Scale 0 (no pain) to 10 (worst possible pain)
Time frame: Before and after first mobilization day 1
Amount of chest tube output
measured in mL
Time frame: after 24 hours and up to removal (max. up to 30 days)
Rate re-exploration because of bleeding
Re-exploration due to haemorrhage or signs of tamponade \< 24 hours of surgery
Time frame: up to 30-day follow-up
Number of re-exploration due to tamponade
Re-exploration due to clinical signs of tamponade \> 24 hours after surgery
Time frame: up to 30-day follow-up
Time until chest tube removal
Measured in hours after completed surgery
Time frame: In-hospital
Length of stay on cardiac surgery intensive care unit
Number of nights
Time frame: In-hospital
Length of hospital stay after surgery
Days
Time frame: up to 30-day follow-up
Rate of infection requiring antibiotic treatment:
Number of: * Superficial wound infection (sternal or saphenous vein harvest site) * Deep wound infection (sternal or saphenous vein harvest site) * Pneumonia * Urinary tract infection * Antibiotic treatment for fever of unknown origin.
Time frame: up to 30-day follow-up
Rate of new-onset atrial fibrillation
New-onset postoperative atrial fibrillation requring intervention (drug or defibrillation)
Time frame: up to 30-day follow-up
Re-hospitalization due to pleural or pericardial effusion up to 30-day follow-up
Number and length of stay
Time frame: up to 30-day follow-up
Rate of acute kidney injury
Classified according to the Acute Kidney Injury Network (AKIN) classification: Stage 1: Creatinine × 1.5 - 2.0 from baseline Stage 2: Creatinine × 2.0-3.0 (i.e. doubled or tripled creatinine) Stage 3: Creatinine \> 3.0 x baseline level OR initiation of renal replacement therapy
Time frame: up to 30-day follow-up
Duration of mechanical ventilation
Measured in hours after completed surgery
Time frame: In-hospital (max up to 30 days)
Early postoperative respiratory function
PaO2/FiO2 ratio
Time frame: after first mobilization day 1
Need for supplemental oxygen
Days
Time frame: In-hospital (max up to 30 days)
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