Timing for Removal of Chest Tubes in Adult Cardiac Surgery

Pain, Postoperative Clinical Trial

Official title:

Timing for Removal of Chest Tubes in Adult Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04487262
• Other study ID #: 1-10-72-1-20
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2023
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 515
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Cardiac surgery
Elective open heart surgery

Locations

Country	Name	City	State
Denmark	Dep. of Cardiothoracic Surgery, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Andreasen JJ, Sorensen GV, Abrahamsen ER, Hansen-Nord E, Bundgaard K, Bendtsen MD, Troelsen P. Early chest tube removal following cardiac surgery is associated with pleural and/or pericardial effusions requiring invasive treatment. Eur J Cardiothorac Surg. 2016 Jan;49(1):288-92. doi: 10.1093/ejcts/ezv005. Epub 2015 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of postoperative pleural and/or pericardial effusion	Effusion requiring invasive drainage	up to 30 days after surgery
Secondary	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
Secondary	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
Secondary	Intensity of postoperative pain	Measured as NRS score: Scale 0 (no pain) to 10 (worst possible pain)	Before and after first mobilization day 1
Secondary	Amount of chest tube output	measured in mL	after 24 hours and up to removal (max. up to 30 days)
Secondary	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
Secondary	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
Secondary	Time until chest tube removal	Measured in hours after completed surgery	In-hospital
Secondary	Length of stay on cardiac surgery intensive care unit	Number of nights	In-hospital
Secondary	Length of hospital stay after surgery	Days	up to 30-day follow-up
Secondary	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
Secondary	Rate of new-onset atrial fibrillation	New-onset postoperative atrial fibrillation requring intervention (drug or defibrillation)	up to 30-day follow-up
Secondary	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
Secondary	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
Secondary	Duration of mechanical ventilation	Measured in hours after completed surgery	In-hospital (max up to 30 days)
Secondary	Early postoperative respiratory function	PaO2/FiO2 ratio	after first mobilization day 1
Secondary	Need for supplemental oxygen	Days	In-hospital (max up to 30 days)