Pleural Effusions Post Coronary Artery Bypass Graft Clinical Trial
Official title:
Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery
NCT number | NCT02147821 |
Other study ID # | REB13-1374 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | March 2018 |
Verified date | May 2018 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 162 |
Est. completion date | March 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Center | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pleural Effusion | Primary outcome is rate of pleural effusions in a 6 week postoperative period of CABG. | 6 weeks | |
Secondary | 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 |