Timing for Removal of Chest Tubes in Adult Cardiac Surgery

NCT04487262 | Terminated

• 1 other identifier: 1-10-72-1-20
• Study Type: interventional
• Target: 515
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Surgery, Heart; Chest Tube; Effusion, Pleural; Complications, Postoperative; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Rate of postoperative pleural and/or pericardial effusion

  Effusion requiring invasive drainage

  up to 30 days after surgery

Secondary Outcomes (16)

• Quantity of opiod consumption

  During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days

• Quantity of non-steroidal anti-inflammatory drug consumption

  During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days

• Intensity of postoperative pain

  Before and after first mobilization day 1

• Amount of chest tube output

  after 24 hours and up to removal (max. up to 30 days)

• Rate re-exploration because of bleeding

  up to 30-day follow-up

Study Arms (2)

Day O chest tube removal

ACTIVE COMPARATOR

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

Procedure: Cardiac surgery

Day 1 chest tube removal

ACTIVE COMPARATOR

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.

Procedure: Cardiac surgery

Interventions

Cardiac surgery PROCEDURE

Elective open heart surgery

Day 1 chest tube removal; Day O chest tube removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (1)

Dep. of Cardiothoracic Surgery, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related 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.

  PMID: 25661079 BACKGROUND

MeSH Terms

Conditions

Pleural Effusion; Pain, Postoperative; Postoperative Complications

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Ivy Susanne Modrau, MD, dr.med.

  Consultant Cardiac Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiac Surgeon, Associate Professor

Model Details: Prospective cluster-randomized parallel study

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 27, 2020
• Study Start: September 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available beginning immediately and ending five years after article publication.
• 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.

Locations

DK (1)