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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2018
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
No Pleural Chest Tube


Locations

Country Name City State
Canada Foothills Medical Center Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

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