Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery (Blake)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pericardial Effusion Late Cardiac Tamponade Surgical Reintervention |
Device: Blake Drains (Blake drain, Ethicon USA) Device: Standard mediastinal drainage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial |
- Any pericardial effusion of 15 mm or more as measured on postoperative transthoracic echocardiogram on day 5 and late cardiac tamponade requiring surgical reintervention. [ Time Frame: Day 5 - post surgery ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: Days 1 or till discharge - post surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2008 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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)
19F Blake drain located in the posterior pericardial cavity
Other Name: Blake drain: prolonged mediastinal drainage
|
|
Active Comparator: 2
mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum.
|
Device: Standard mediastinal drainage
Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum
Other Name: mediastinal drainage
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Quebec | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Principal Investigator: | Phillippe Demers, MD | Montreal Heart Institute |
More Information
Publications:
| Responsible Party: | Philippe Demers M.D., M.Sc., FRCSC, Montreal Heart Institute - Cardiac surgeon |
| ClinicalTrials.gov Identifier: | NCT00684125 History of Changes |
| Other Study ID Numbers: | ICM 07-934 |
| Study First Received: | May 21, 2008 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Montreal Heart Institute:
|
late cardiac tamponade |
Additional relevant MeSH terms:
|
Cardiac Tamponade Pericardial Effusion Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013