Chest Tube, Effusion Pleural, Heart Surgery, Pain, Postoperative
Conditions
Keywords
Surgery, Heart, Chest Tube, Effusion, Pleural, Complications, Postoperative, Pain, Postoperative
Brief summary
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.
Interventions
PROCEDURECardiac surgery
Elective open heart surgery
Sponsors
Aarhus University Hospital Skejby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective cluster-randomized parallel study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative pleural and/or pericardial effusion | up to 30 days after surgery | Effusion requiring invasive drainage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of non-steroidal anti-inflammatory drug consumption | During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days | Daily dose of NSAIDs standardized by using the manufacturers' recommended minimum daily maintenance doses for rheumatoid arthritis as 1 dose unit |
| Intensity of postoperative pain | Before and after first mobilization day 1 | Measured as NRS score: Scale 0 (no pain) to 10 (worst possible pain) |
| Amount of chest tube output | after 24 hours and up to removal (max. up to 30 days) | measured in mL |
| Rate re-exploration because of bleeding | up to 30-day follow-up | Re-exploration due to haemorrhage or signs of tamponade \< 24 hours of surgery |
| Number of re-exploration due to tamponade | up to 30-day follow-up | Re-exploration due to clinical signs of tamponade \> 24 hours after surgery |
| Time until chest tube removal | In-hospital | Measured in hours after completed surgery |
| Length of stay on cardiac surgery intensive care unit | In-hospital | Number of nights |
| Quantity of opiod consumption | During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days | Measured as oral morphine equivalent daily dose (mg/day) |
| Rate of infection requiring antibiotic treatment: | up to 30-day follow-up | 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. |
| Rate of new-onset atrial fibrillation | up to 30-day follow-up | New-onset postoperative atrial fibrillation requring intervention (drug or defibrillation) |
| Re-hospitalization due to pleural or pericardial effusion up to 30-day follow-up | up to 30-day follow-up | Number and length of stay |
| Rate of acute kidney injury | up to 30-day follow-up | 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 |
| Duration of mechanical ventilation | In-hospital (max up to 30 days) | Measured in hours after completed surgery |
| Early postoperative respiratory function | after first mobilization day 1 | PaO2/FiO2 ratio |
| Need for supplemental oxygen | In-hospital (max up to 30 days) | Days |
| Length of hospital stay after surgery | up to 30-day follow-up | Days |
Countries
Denmark
Outcome results
None listed