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

NCT ID: NCT02147821

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type: EXPERIMENTAL

No Pleural Chest Tube

Intervention Type: PROCEDURE

Interventions

No Pleural Chest Tube

Intervention Type: PROCEDURE

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

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

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Aaron Spooner

MD, MMgt, HBSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Foothills Medical Center

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB13-1374

Identifier Type: -

Identifier Source: org_study_id