OBJECTIVES: The purposes of this study were to evaluate the clinical safety and efficacy of 10F, 15F, and 19F Blake drains (Ethicon, Sommerville, NJ) in a pediatric population after cardiac surgery and to compare their clinical effect with that of conventional chest drains. METHODS: From January 2002 through December 2004, a prospective randomized trial was conducted on 189 patients who underwent surgical intervention for congenital heart disease at our institution. Statistical analyses were conducted to test the null hypothesis that there was no difference in the incidence of pericardial or pleural effusion requiring drainage. Secondary end points included total volume of drainage, drain size, and time to drain removal. RESULTS: Ninety-eight patients (group A) received Blake drains, and 91 patients (group B) received conventional chest drains. There were no statistically significant difference in age, weight at the time of surgical intervention, open- and closed-heart procedures, and number of drains applied. Statistically significant differences were detected in the frequency of pericardial effusion (group A: 1.1% vs group B: 4.8%, P < .01), pleural effusion (group A: 1.1% vs group B: 5.3%, P < .01), size of the drain (group A: 12.37 French +/- 1.72 French vs group B: 16.81 French +/- 0.70 French, P < .001), and time to removal (group A: 43.75 +/- 20.76 hours vs group B: 55.62 +/- 26.48 hours, P < .001). CONCLUSIONS:Blake drains are safer and more efficient than conventional chest tubes in pediatric populations after cardiac surgery. In comparison with conventional chest tubes, they showed fewer occurrences of effusions and the same amount of fluid drained but smaller size and earlier removal.
RCT Entities:
OBJECTIVES: The purposes of this study were to evaluate the clinical safety and efficacy of 10F, 15F, and 19F Blake drains (Ethicon, Sommerville, NJ) in a pediatric population after cardiac surgery and to compare their clinical effect with that of conventional chest drains. METHODS: From January 2002 through December 2004, a prospective randomized trial was conducted on 189 patients who underwent surgical intervention for congenital heart disease at our institution. Statistical analyses were conducted to test the null hypothesis that there was no difference in the incidence of pericardial or pleural effusion requiring drainage. Secondary end points included total volume of drainage, drain size, and time to drain removal. RESULTS: Ninety-eight patients (group A) received Blake drains, and 91 patients (group B) received conventional chest drains. There were no statistically significant difference in age, weight at the time of surgical intervention, open- and closed-heart procedures, and number of drains applied. Statistically significant differences were detected in the frequency of pericardial effusion (group A: 1.1% vs group B: 4.8%, P < .01), pleural effusion (group A: 1.1% vs group B: 5.3%, P < .01), size of the drain (group A: 12.37 French +/- 1.72 French vs group B: 16.81 French +/- 0.70 French, P < .001), and time to removal (group A: 43.75 +/- 20.76 hours vs group B: 55.62 +/- 26.48 hours, P < .001). CONCLUSIONS: Blake drains are safer and more efficient than conventional chest tubes in pediatric populations after cardiac surgery. In comparison with conventional chest tubes, they showed fewer occurrences of effusions and the same amount of fluid drained but smaller size and earlier removal.