An interventional study of Medela Thopaz Thoracic Drainage System and Atrium Express Dry Seal Chest Drain in Lung Neoplasms and Pleural Effusion, sponsored by McMaster University. Completed at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-05-13.
Sponsored by McMaster University · Not applicable, Interventional, and Supportive care
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 103 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medela Thopaz Thoracic Drainage System
Device: Medela Thopaz Thoracic Drainage System
Atrium Express Dry Seal Chest Drain
Device: Atrium Express Dry Seal Chest Drain
Overall quantity of pleural effusion (mL)
Overall amount of pleural effusion drained from patients undergoing lung resection until chest tubes removal, comparing the two systems. Fluid output will be measured and recorded every 8 hours, using a digital (Medela®) Thopaz drainage system or traditional non-digital Express (Atrium®) drainage system and the output will be recorded in milliliters. Chest tubes will be removed whenever the drainage is less than 350ml per 24 hours and when there is no active air leak
Time frame: From one hour after surgery to chest tube removal, estimated duration of 3 days
Time chest tubes remain in-situ
Measurement of the time (in hours and days) that chest tubes remain in-situ following an operative procedure
Time frame: An expected average of 3 days starting from transfer from OR
Length of hospital stay
Time frame: Estimated to be 4 days from admittance to discharge
Mortality and Morbidity
Overall mortality and morbidity
Time frame: 90 days of surgery
Occurrence of dyspnea related to the reoccurrence of pleural effusion
Time frame: Estimated to be 4 days from admittance to discharge
Clinically significant reintervention needed
Clinically significant reintervention needed, including 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
Time frame: Estimated to be 4 days from admittance to discharge
Readmission to hospital rates
Time frame: Within 1 month of discharge
Comparison of pleural fluid/plasma protein ratio and inflammatory mediators
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
Time frame: Samples to be taken in OR and on days 1, 2, 3 and 4 post-surgery
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
McMaster University