Timing for Removal of Chest Tubes in Adult Cardiac Surgery

August 6, 2023 updated by: Ivy susanne Modrau, MD, Aarhus University Hospital Skejby

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
515

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  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
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:

  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
Elective open heart surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of postoperative pleural and/or pericardial effusion
Time Frame: up to 30 days after surgery
Effusion requiring invasive drainage
up to 30 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantity of opiod consumption
Time Frame: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
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
Time Frame: During 1st, 2nd, 3rd, and 4th postoperative day, and in total after 30 days
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
Time Frame: Before and after first mobilization day 1
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
Time Frame: after 24 hours and up to removal (max. up to 30 days)
measured in mL
after 24 hours and up to removal (max. up to 30 days)
Rate re-exploration because of bleeding
Time Frame: up to 30-day follow-up
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
Time Frame: up to 30-day follow-up
Re-exploration due to clinical signs of tamponade > 24 hours after surgery
up to 30-day follow-up
Time until chest tube removal
Time Frame: In-hospital
Measured in hours after completed surgery
In-hospital
Length of stay on cardiac surgery intensive care unit
Time Frame: In-hospital
Number of nights
In-hospital
Length of hospital stay after surgery
Time Frame: up to 30-day follow-up
Days
up to 30-day follow-up
Rate of infection requiring antibiotic treatment:
Time Frame: up to 30-day follow-up

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
Time Frame: up to 30-day follow-up
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
Time Frame: up to 30-day follow-up
Number and length of stay
up to 30-day follow-up
Rate of acute kidney injury
Time Frame: up to 30-day follow-up

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
Time Frame: In-hospital (max up to 30 days)
Measured in hours after completed surgery
In-hospital (max up to 30 days)
Early postoperative respiratory function
Time Frame: after first mobilization day 1
PaO2/FiO2 ratio
after first mobilization day 1
Need for supplemental oxygen
Time Frame: In-hospital (max up to 30 days)
Days
In-hospital (max up to 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital Skejby

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ivy Susanne Modrau, MD, dr.med., Consultant Cardiac Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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