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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms; Pleural Effusion
• Intervention / Treatment: Device: Medela Thopaz Thoracic Drainage System; Device: Atrium Express Dry Seal Chest Drain

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must be between 18 and 90 years of age
• Diagnosed with suspected lung cancer or metastatic cancer to the lungs
• Surgery must include lung resection (Wedge; single or multiple, lobectomy or bi-lobectomy) and mediastinal lymph nodes sampling or dissection
• Demonstrate an ability for understanding the study procedures
• Demonstrate willingness to remain on-study for the complete duration
• Must be able to give informed consent to participate at this study.

Exclusion Criteria:

• Patients undergoing lung resection due to non-malignancy
• Patients undergoing pneumonectomy
• Patients treated with neo-adjuvant chemotherapy and/or radiation prior to surgery
• Patients with previous lung resection on the ipsilateral side
• Patients with evidence of chronic heart failure (i.e. NYHA class III, IV; current treatment with diuretics for heart failure, and/or LVEF <35%)
• Patients with chronic renal failure (i.e. estimated CCr of < 50ml/min/m2)
• Patients with history of or ongoing liver disease, expressed by ascites or previous peritoneal tapping for ascites.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digital thoracic drainage system; Medela Thopaz Thoracic Drainage System	Device: Medela Thopaz Thoracic Drainage System
Active Comparator: Non-digital thoracic drainage system; Atrium Express Dry Seal Chest Drain	Device: Atrium Express Dry Seal Chest Drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From one hour after surgery to chest tube removal, estimated duration of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time chest tubes remain in-situ	Measurement of the time (in hours and days) that chest tubes remain in-situ following an operative procedure	An expected average of 3 days starting from transfer from OR
Length of hospital stay		Estimated to be 4 days from admittance to discharge
Mortality and Morbidity	Overall mortality and morbidity	90 days of surgery
Occurrence of dyspnea related to the reoccurrence of pleural effusion		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	Estimated to be 4 days from admittance to discharge
Readmission to hospital rates		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	Samples to be taken in OR and on days 1, 2, 3 and 4 post-surgery

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 21, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Drainage; Chest tubes
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Pleural Effusion
• Other Study ID Numbers: SJHHPleuralDrainageComparsion; R.P. 12-3800 (Other Identifier: Hamilton Integrated Research Ethics Board)