Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery

Not Applicable

Completed

• Conditions: Pericardial Effusion; Late Cardiac Tamponade; Surgical Reintervention
• Interventions: Device: Blake Drains (Blake drain, Ethicon USA); Device: Standard mediastinal drainage

• Registration Number: NCT00684125
• Lead Sponsor: Montreal Heart Institute

Brief Summary

The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. A prospective randomized trial.

Detailed Description

The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. Patients undergoing aortic and / or valvular surgery will be randomized in two groups. In group A, mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity. In group B, mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. In both groups, conventional chest tubes will be removed on the first postoperative day, while patients in the group A will have prolonged drainage using the Blake drain until output is less than 50 ml over 24 hour. Patients will be followed during their postoperative course for occurrence of significant pericardial effusion as detected on routine echocardiogram and late cardiac tamponade requiring reintervention.

Study Timeline

• Study First Submitted: 2008-05-21
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-26
• Study Start: 2008-06
• Primary Completion: 2010-05
• Study Completion: 2010-07
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients aged between 18 and 90 years old, undergoing either surgery of the ascending and/or transverse aorta, or surgery of the mitral and/or aortic valves
• Availability for follow-up at the Montreal Heart Institute Exclusion criteria

Exclusion Criteria

• Emergency surgery
• Unavailability for follow-up at the Montreal Heart Institute

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Blake Drains (Blake drain, Ethicon USA)	mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity.
2	Standard mediastinal drainage	mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum.

Primary Outcome Measures

Name	Time	Method
Any pericardial effusion of 15 mm or more as measured on postoperative transthoracic echocardiogram on day 5 and late cardiac tamponade requiring surgical reintervention.	Day 5 - post surgery

Secondary Outcome Measures

Name	Time	Method
Total volume of mediastinal drainage. Pain intensity on postoperative days 1 to 5. Incidence of postoperative atrial fibrillation Drain-associated infection or any other drain-associated adverse event.	Days 1 or till discharge - post surgery

Trial Locations

Locations (1)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada