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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
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| 2 | Active Comparator | mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blake Drains (Blake drain, Ethicon USA) | Device | 19F Blake drain located in the posterior pericardial cavity |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillippe Demers, MD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16798298 | Background | Eryilmaz S, Emiroglu O, Eyileten Z, Akar R, Yazicioglu L, Tasoz R, Kaya B, Uysalel A, Ucanok K, Corapcioglu T, Ozyurda U. Effect of posterior pericardial drainage on the incidence of pericardial effusion after ascending aortic surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):27-31. doi: 10.1016/j.jtcvs.2006.01.049. | |
| 16733162 |
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| ID | Term |
|---|---|
| D010490 | Pericardial Effusion |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Standard mediastinal drainage | Device | Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum |
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| Agati S, Mignosa C, Gitto P, Trimarchi ES, Ciccarello G, Salvo D, Trimarchi G. A method for chest drainage after pediatric cardiac surgery: a prospective randomized trial. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1306-9. doi: 10.1016/j.jtcvs.2006.02.013. |
| 15539727 | Background | Ege T, Tatli E, Canbaz S, Cikirikcioglu M, Sunar H, Ozalp B, Duran E. The importance of intrapericardial drain selection in cardiac surgery. Chest. 2004 Nov;126(5):1559-62. doi: 10.1378/chest.126.5.1559. |
| 11016389 | Background | Obney JA, Barnes MJ, Lisagor PG, Cohen DJ. A method for mediastinal drainage after cardiac procedures using small silastic drains. Ann Thorac Surg. 2000 Sep;70(3):1109-10. doi: 10.1016/s0003-4975(00)01800-2. |
| 12400760 | Background | Kuvin JT, Harati NA, Pandian NG, Bojar RM, Khabbaz KR. Postoperative cardiac tamponade in the modern surgical era. Ann Thorac Surg. 2002 Oct;74(4):1148-53. doi: 10.1016/s0003-4975(02)03837-7. |
| 16928545 | Background | Shah A, van den Brink A, de Mol B. Raised international normalized ratio: an early warning for a late cardiac tamponade? Ann Thorac Surg. 2006 Sep;82(3):1090-1. doi: 10.1016/j.athoracsur.2006.01.035. |
| 23575759 | Derived | Moss E, Miller CS, Jensen H, Basmadjian A, Bouchard D, Carrier M, Perrault LP, Cartier R, Pellerin M, Demers P. A randomized trial of early versus delayed mediastinal drain removal after cardiac surgery using silastic and conventional tubes. Interact Cardiovasc Thorac Surg. 2013 Jul;17(1):110-5. doi: 10.1093/icvts/ivt123. |