Clinical trial NCT04487262: Timing for Removal of Chest Tubes in Adult Cardiac Surgery
Official title: Timing for Removal of Chest Tubes in Adult Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Surgery
Chest Tube
Effusion Pleural
Pain, Postoperative
Keywords: Surgery, Heart
Chest Tube
Effusion, Pleural
Complications, Postoperative
Pain, Postoperative
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cluster-randomized parallel study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of postoperative pleural and/or pericardial effusion
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Quantity of opiod consumption
timeFrame: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
measure: Quantity of non-steroidal anti-inflammatory drug consumption
timeFrame: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
measure: Intensity of postoperative pain
timeFrame: Before and after first mobilization day 1
measure: Amount of chest tube output
timeFrame: after 24 hours and up to removal (max. up to 30 days)
measure: Rate re-exploration because of bleeding
timeFrame: up to 30-day follow-up
measure: Number of re-exploration due to tamponade
timeFrame: up to 30-day follow-up
measure: Time until chest tube removal
timeFrame: In-hospital
measure: Length of stay on cardiac surgery intensive care unit
timeFrame: In-hospital
measure: Length of hospital stay after surgery
timeFrame: up to 30-day follow-up
measure: Rate of infection requiring antibiotic treatment:
timeFrame: up to 30-day follow-up
measure: Rate of new-onset atrial fibrillation
timeFrame: up to 30-day follow-up
measure: Re-hospitalization due to pleural or pericardial effusion up to 30-day follow-up
timeFrame: up to 30-day follow-up
measure: Rate of acute kidney injury
timeFrame: up to 30-day follow-up
measure: Duration of mechanical ventilation
timeFrame: In-hospital (max up to 30 days)
measure: Early postoperative respiratory function
timeFrame: after first mobilization day 1
measure: Need for supplemental oxygen
timeFrame: In-hospital (max up to 30 days)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dep. of Cardiothoracic Surgery, Aarhus University Hospital
Study officials:
affiliation: Consultant Cardiac Surgeon
name: Ivy Susanne Modrau, MD, dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.