Timing for Removal of Chest Tubes in Adult Cardiac Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Timing for Removal of Chest Tubes in Adult Cardiac Surgery

Conditions
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Heart Surgery, Chest Tube, Effusion Pleural, Pain, Postoperative

Intervention / Treatment
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* Procedure: Cardiac surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective cluster-randomized parallel study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day O chest tube removal<br>Chest tubes maybe removed ten hours after arrival at the intensive care provided standardized removal criteria are fulfilled: blood loss through chest tubes less than 200 ml during the last four hours no air leak the patient extubated and mobilized It remains at the discretion of the attending cardiac surgeon to postpone chest tube removal in cases of increased bleeding risk, due to circumstances which develop during the perioperative period | Procedure: Cardiac surgery<br>* Elective open heart surgery<br>|
| Active Comparator: Day 1 chest tube removal<br>Chest tubes are removed in the early morning of the first postoperative day, provided standardized removal criteria are fulfilled: blood loss through chest tubes less than 200 ml during the last four hours no air leak the patient extubated and mobilized It remains at the discretion of both the attending surgeon and anestesiologist to remove chest tubes prematurely in cases of drain-induced, severe analgetic resistant, intractable pain resistant to analgetic treatment. | Procedure: Cardiac surgery<br>* Elective open heart surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative pleural and/or pericardial effusion | Effusion requiring invasive drainage | up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of opiod consumption | Measured as oral morphine equivalent daily dose (mg/day) | 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 | 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) | Before and after first mobilization day 1 | 
| Amount of chest tube output | measured in mL | 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 | 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 | up to 30-day follow-up | 
| Time until chest tube removal | Measured in hours after completed surgery | In-hospital | 
| Length of stay on cardiac surgery intensive care unit | Number of nights | In-hospital | 
| Length of hospital stay after surgery | Days | 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. | up to 30-day follow-up | 
| Rate of new-onset atrial fibrillation | New-onset postoperative atrial fibrillation requring intervention (drug or defibrillation) | 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 | 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 | up to 30-day follow-up | 
| Duration of mechanical ventilation | Measured in hours after completed surgery | In-hospital (max up to 30 days) | 
| Early postoperative respiratory function | PaO2/FiO2 ratio | after first mobilization day 1 | 
| Need for supplemental oxygen | Days | In-hospital (max up to 30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Heart, Chest Tube, Effusion, Pleural, Complications, Postoperative, Pain, Postoperative