Comparison of Pleural Drainage Systems on Reducing Pleural Effusion Formation Following Lung Resection

Lung Neoplasms Clinical Trial

Official title: Effect of the Use of a Digital Pleural Drainage System on Reducing Pleural Effusion Formation Following Lung Resection

Status Completed

Clinical Trial Summary

The chest cavity contains a small amount of fluid (pleural effusion). In normal circumstances this fluid is kept in balance. When surgery is performed on the lung, there can be accumulation of more fluid due to many causes. In order to drain this additional amount of pleural fluid, chest tube(s) are left in the thoracic cage after a lung resection procedure. The investigators are attempting to reduce the amount of pleural fluid production and formation by using a more balanced thoracic drainage system, which adjusts the amount of suction depending on the needs of the patient. That way, the amount of inflammation in the thoracic cage might be smaller, and hence less fluid will be formed. By this, the investigators are hoping that the chest tubes can be removed earlier, and the patients can be discharged faster and will potentially have a lower rate of re-admission to the hospital after surgery due to problems related to the fluid in the thoracic cage.

Clinical Trial Description

Length of hospital stay after lung surgery depends mainly on duration of chest tube drainage. Patients undergoing lung resection have 1 or 2 chest tubes in the pleural cavity to evacuate air and pleural fluid. Digital drainage systems (recently approved for usage in Canada) offer the advantage of maintaining a stable intrapleural pressure through interactive balancing depending on the needs of the patient. In contrast, the traditional chest tube system offers continuous suctioning and negative pleural pressure, regardless the ongoing needs of the patients. Therefore, usage of digital drainage system (already shown to be beneficial in reducing the duration of air leak after lung resection when compared to the traditional system) may potentially reduce the amount of pleural drainage and hence reduce the duration of chest tube drainage until removal and overall patient's length of stay in hospital.

The following is a proposal for a randomized, controlled trial where patients will be randomized to have either a digital drainage system (intervention group) or non-digital drainage system, a conventional system currently used to drain the pleural space (the control group) after major lung resection for malignancy. The primary outcome of this study is comparing the overall amounts of pleural fluid drainage after major lung resection using two different chest tube drainage systems. Secondary outcomes will include measurement in time (hours) that chest tubes remain in-situ before removal following an operative procedure, and overall reduction in the length of stay (LOS) of patients; 90 days overall mortality and morbidity; occurrence of dyspnea related to the reoccurrence of pleural effusion; clinically significant reintervention needed (thoracocentesis, re-insertion of chest drain(s) and number and type of imaging studies required which are related to potential re-accumulation of pleural effusion); readmission rates within 1 month of discharge; comparison of pleural fluid/plasma protein ratio and inflammatory mediators (IL-6, IL-8, IL-10, IL-1RA, TNF-α) between the two groups, a potential indicator for differences in pleural inflammation and permeability between the two groups. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Neoplasms
• Pleural Effusion

• NCT number: NCT01776372
• Study type: Interventional
• Source: McMaster University
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: December 2013