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

NCT02147821 | Completed

• 1 other identifier: REB13-1374
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Pleural Effusions Post Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

• Pleural Effusion

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

  6 weeks

Secondary Outcomes (1)

• Postoperative Respiratory Status

  1 week after CABG

Study Arms (2)

Standard

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

No Pleural Chest Tube PROCEDURE

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MMgt, HBSc

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: May 28, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

CA (1)