Timing for Removal of Chest Tubes in Adult Cardiac Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative; Heart Surgery; Effusion Pleural; Chest Tube
• Intervention / Treatment: Procedure: Cardiac surgery

• Study Type: Interventional
• Enrollment (Actual): 515
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Dep. of Cardiothoracic Surgery, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Day O chest tube removal; 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; Elective open heart surgery
Active Comparator: Day 1 chest tube removal; 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; Elective open heart surgery

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Investigators: Principal Investigator: Ivy Susanne Modrau, MD, dr.med., Consultant Cardiac Surgeon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pain, Postoperative; Chest Tube; Surgery, Heart; Effusion, Pleural; Complications, Postoperative
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 1-10-72-1-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual-level deidentified patient data that support the findings of this study, and statistical analysis plan are available upon reasonable request.
• IPD Sharing Time Frame: Data will be available beginning immediately and ending five years after article publication.
• IPD Sharing Access Criteria: Data sharing with other researchers requires a methodologically sound proposal (detailed protocol for the proposed study, information about the funding and resources) and approval by the Danish Data Protection Agency.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No