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Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery

Primary Purpose

Pleural Effusions Post Coronary Artery Bypass Graft

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No Pleural Chest Tube
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusions Post Coronary Artery Bypass Graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients must be undergoing CABG at our institution with the attempted harvest of a LIMA and/or RIMA
  • pleura must be entered in order for patients to be included.

Exclusion Criteria:

  • cardiac surgery where the pleura is not entered
  • previous surgery where the pleura was entered
  • other pre-existing pleural diseases or fibrosis
  • Patients currently participating in other studies
  • Patients presenting with emergent need for bypass

Sites / Locations

  • Foothills Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard

Intervention

Arm Description

Standard treatment will be defined as current practice whereby two mediastinal chest tubes are used for drainage, as well as an additional pleural tube if the pleura is opened during surgery. As part of current standard practice, the pleural and mediastinal spaces will be suctioned during the achievement of hemostasis prior to the insertion of chest tubes.

The treatment arm of the study will involve standard placement of the mediastinal tubes with the exclusion of the pleural tube.

Outcomes

Primary Outcome Measures

Pleural Effusion
Primary outcome is rate of pleural effusions in a 6 week postoperative period of CABG.

Secondary Outcome Measures

Postoperative Respiratory Status
Respiratory status will be defined by measurement of oxygen requirement as well as documented levels of incentive spirometry, as well as length of mechanical ventilation in ICU.

Full Information

First Posted
May 22, 2014
Last Updated
May 2, 2018
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02147821
Brief Title
Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery
Official Title
Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This prospective randomized controlled trial will examine the efficacy of reducing the number of chest tubes used in the postoperative cardiac surgery patient. Typically used are three chest tubes - two in the mediastinum and one in the pleural space, if opened. The investigators propose that removal of the pleural tube will not impact the rates of clinically significant pleural effusions post cardiac surgery. Patients will be randomized into two groups - one receiving the standard three chest tubes (standard), and the other receiving only mediastinal drains (experimental). The primary outcome will be rates of post-operative pleural effusions as determined by defined interventions, including insertion of a chest tube, thoracentesis, or return to the operating room for primary evacuation of pleural effusion or hemothorax. Secondary outcomes include length of hospital stay, length of mechanical ventilation, postoperative respiratory status, and presence/size of pleural effusions, as well as readmission for pleural effusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusions Post Coronary Artery Bypass Graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
No Intervention
Arm Description
Standard treatment will be defined as current practice whereby two mediastinal chest tubes are used for drainage, as well as an additional pleural tube if the pleura is opened during surgery. As part of current standard practice, the pleural and mediastinal spaces will be suctioned during the achievement of hemostasis prior to the insertion of chest tubes.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The treatment arm of the study will involve standard placement of the mediastinal tubes with the exclusion of the pleural tube.
Intervention Type
Procedure
Intervention Name(s)
No Pleural Chest Tube
Primary Outcome Measure Information:
Title
Pleural Effusion
Description
Primary outcome is rate of pleural effusions in a 6 week postoperative period of CABG.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Postoperative Respiratory Status
Description
Respiratory status will be defined by measurement of oxygen requirement as well as documented levels of incentive spirometry, as well as length of mechanical ventilation in ICU.
Time Frame
1 week after CABG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients must be undergoing CABG at our institution with the attempted harvest of a LIMA and/or RIMA pleura must be entered in order for patients to be included. Exclusion Criteria: cardiac surgery where the pleura is not entered previous surgery where the pleura was entered other pre-existing pleural diseases or fibrosis Patients currently participating in other studies Patients presenting with emergent need for bypass
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada

12. IPD Sharing Statement

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Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery

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