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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01776372
First received: January 21, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Lung Neoplasms
Pleural Effusion
Device: Medela Thopaz Thoracic Drainage System
Device: Atrium Express Dry Seal Chest Drain

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of the Use of a Digital Pleural Drainage System on Reducing Pleural Effusion Formation Following Lung Resection

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Overall quantity of pleural effusion (mL) [ Time Frame: From one hour after surgery to chest tube removal, estimated duration of 3 days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Time chest tubes remain in-situ [ Time Frame: An expected average of 3 days starting from transfer from OR ] [ Designated as safety issue: No ]
    Measurement of the time (in hours and days) that chest tubes remain in-situ following an operative procedure

  • Length of hospital stay [ Time Frame: Estimated to be 4 days from admittance to discharge ] [ Designated as safety issue: No ]
  • Mortality and Morbidity [ Time Frame: 90 days of surgery ] [ Designated as safety issue: Yes ]
    Overall mortality and morbidity

  • Occurrence of dyspnea related to the reoccurrence of pleural effusion [ Time Frame: Estimated to be 4 days from admittance to discharge ] [ Designated as safety issue: No ]
  • Clinically significant reintervention needed [ Time Frame: Estimated to be 4 days from admittance to discharge ] [ Designated as safety issue: No ]
    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

  • Readmission to hospital rates [ Time Frame: Within 1 month of discharge ] [ Designated as safety issue: No ]
  • Comparison of pleural fluid/plasma protein ratio and inflammatory mediators [ Time Frame: Samples to be taken in OR and on days 1, 2, 3 and 4 post-surgery ] [ Designated as safety issue: No ]
    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


Enrollment: 103
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776372

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Yaron Shargall, MD FRCSC McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01776372     History of Changes
Other Study ID Numbers: SJHHPleuralDrainageComparsion, R.P. 12-3800
Study First Received: January 21, 2013
Last Updated: May 12, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Drainage
Chest tubes
Randomized Controlled Trial

Additional relevant MeSH terms:
Lung Neoplasms
Pleural Effusion
Lung Diseases
Neoplasms
Neoplasms by Site
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014