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临床试验/NCT02147821
NCT02147821已完成不适用

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

University of Calgary2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2014年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
162
试验地点
2
主要终点
Pleural Effusion

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Standard

No Intervention

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.

Intervention

Experimental

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

干预措施: No Pleural Chest Tube (Procedure)

结局指标

主要结局

Pleural Effusion

时间窗: 6 weeks

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

次要结局

  • Postoperative Respiratory Status(1 week after CABG)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aaron Spooner

MD, MMgt, HBSc

University of Calgary

研究点 (2)

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