Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial

Conditions
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Pericardial Effusion, Late Cardiac Tamponade, Surgical Reintervention

Intervention / Treatment
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* Device: Blake Drains (Blake drain, Ethicon USA)
* Device: Standard mediastinal drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Device: Blake Drains (Blake drain, Ethicon USA)<br>* 19F Blake drain located in the posterior pericardial cavity<br>* Other names: Blake drain: prolonged mediastinal drainage;|
| Active Comparator: 2<br>mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. | Device: Standard mediastinal drainage<br>* Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum<br>* Other names: mediastinal drainage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late cardiac tamponade