Timing for Removal of Chest Tubes in Adult Cardiac Surgery

Not Applicable

Terminated

• Conditions: Effusion Pleural; Pain, Postoperative; Chest Tube; Heart Surgery
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT04487262
• Lead Sponsor: Aarhus University Hospital Skejby

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2020-09-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 515

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Day O chest tube removal	Cardiac surgery	Chest tubes maybe removed ten hours after arrival at the intensive care provided standardized removal criteria are fulfilled: 1. blood loss through chest tubes less than 200 ml during the last four hours 2. no air leak 3. 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
Day 1 chest tube removal	Cardiac surgery	Chest tubes are removed in the early morning of the first postoperative day, provided standardized removal criteria are fulfilled: 1. blood loss through chest tubes less than 200 ml during the last four hours 2. no air leak 3. 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.

Primary Outcome Measures

Name	Time	Method
Rate of postoperative pleural and/or pericardial effusion	up to 30 days after surgery	Effusion requiring invasive drainage

Secondary Outcome Measures

Name	Time	Method
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
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
Duration of mechanical ventilation	In-hospital (max up to 30 days)	Measured in hours after completed surgery
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
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
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.
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)
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
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
Length of hospital stay after surgery	up to 30-day follow-up	Days
Rate of new-onset atrial fibrillation	up to 30-day follow-up	New-onset postoperative atrial fibrillation requring intervention (drug or defibrillation)
Early postoperative respiratory function	after first mobilization day 1	PaO2/FiO2 ratio
Need for supplemental oxygen	In-hospital (max up to 30 days)	Days

Trial Locations

Locations (1)

Dep. of Cardiothoracic Surgery, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark