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OpenTrials
Completed

NCT Number: NCT02147821

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Pleural Chest Tube

Procedure

Primary outcomes

  1. Pleural Effusion

    Time frame: 6 weeks

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

Secondary outcomes

  1. Postoperative Respiratory Status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 28, 2014
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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