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

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusions Post Coronary Artery Bypass Graft
• Intervention / Treatment: Procedure: No Pleural Chest Tube

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; 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.
Experimental: Intervention; The treatment arm of the study will involve standard placement of the mediastinal tubes with the exclusion of the pleural tube.	Procedure: No Pleural Chest Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pleural Effusion	Primary outcome is rate of pleural effusions in a 6 week postoperative period of CABG.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week after CABG

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: May 22, 2014
• First Submitted That Met QC Criteria: May 27, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: REB13-1374