Comparison of Pleural Drainage Systems on Reducing Pleural Effusion Formation Following Lung Resection
Condition: Lung Neoplasms; Pleural Effusion
MeSH terms: Lung Neoplasms; Pleural Effusion
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Medela Thopaz Thoracic Drainage System; Atrium Express Dry Seal Chest Drain
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Drainage; Chest tubes; Randomized Controlled Trial