Timing for Removal of Chest Tubes in Adult Cardiac Surgery

NCT ID: NCT04487262

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 515 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Day O chest tube removal

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

Group Type: ACTIVE_COMPARATOR

Cardiac surgery

Intervention Type: PROCEDURE

Elective open heart surgery

Day 1 chest tube removal

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.

Group Type: ACTIVE_COMPARATOR

Cardiac surgery

Intervention Type: PROCEDURE

Elective open heart surgery

Interventions

Cardiac surgery

Elective open heart surgery

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: lead

Responsible Party

Ivy susanne Modrau, MD

Consultant Cardiac Surgeon, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivy Susanne Modrau, MD, dr.med.

Role: PRINCIPAL_INVESTIGATOR

Consultant Cardiac Surgeon

Locations

Dep. of Cardiothoracic Surgery, Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

References

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.

Reference Type: BACKGROUND

PMID: 25661079 (View on PubMed)

Other Identifiers

1-10-72-1-20

Identifier Type: -

Identifier Source: org_study_id