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

NCT01776372 | Completed

• 2 other identifiers: SJHHPleuralDrainageComparsionR.P. 12-3800
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasms; Pleural Effusion

Keywords

Drainage; Chest tubes; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time chest tubes remain in-situ

  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

  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

  Estimated to be 4 days from admittance to discharge

Study Arms (2)

Digital thoracic drainage system

ACTIVE COMPARATOR

Medela Thopaz Thoracic Drainage System

Device: Medela Thopaz Thoracic Drainage System

Non-digital thoracic drainage system

ACTIVE COMPARATOR

Atrium Express Dry Seal Chest Drain

Device: Atrium Express Dry Seal Chest Drain

Interventions

Medela Thopaz Thoracic Drainage System DEVICE

Digital thoracic drainage system

Atrium Express Dry Seal Chest Drain DEVICE

Non-digital thoracic drainage system

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Pleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases

Study Officials

• Yaron Shargall, MD FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 28, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

CA (1)