Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery

NCT00684125 | Completed

• 1 other identifier: ICM 07-934
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pericardial Effusion; Late Cardiac Tamponade; Surgical Reintervention

Keywords

late cardiac tamponade

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Device: Blake Drains (Blake drain, Ethicon USA)

2

ACTIVE COMPARATOR

mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum.

Device: Standard mediastinal drainage

Interventions

Blake Drains (Blake drain, Ethicon USA) DEVICE

19F Blake drain located in the posterior pericardial cavity

Also known as: Blake drain: prolonged mediastinal drainage

1

Standard mediastinal drainage DEVICE

Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum

Also known as: mediastinal drainage

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Johnson & Johnson: collaborator

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (7)

• 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.

  PMID: 16798298 BACKGROUND

• 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.

  PMID: 16733162 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.

  PMID: 15539727 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.

  PMID: 11016389 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.

  PMID: 12400760 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.

  PMID: 16928545 BACKGROUND

• 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.

  PMID: 23575759 DERIVED

MeSH Terms

Conditions

Pericardial Effusion

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Phillippe Demers, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 26, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

CA (1)