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

Not Applicable

Completed

• Conditions: Pleural Effusions Post Coronary Artery Bypass Graft
• Interventions: Procedure: No Pleural Chest Tube

• Registration Number: NCT02147821
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Study Start: 2014-08
• Primary Completion: 2017-11
• Study Completion: 2018-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	No Pleural Chest Tube	The treatment arm of the study will involve standard placement of the mediastinal tubes with the exclusion of the pleural tube.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative Respiratory Status	1 week after CABG	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.

Trial Locations

Locations (1)

Foothills Medical Center; 🇨🇦 Calgary, Alberta, Canada