Effect of the Use of a Digital Pleural Drainage System on Reducing Pleural Effusion Formation Following Lung Resection
18 Years
90 Years
Both
Lung Neoplasms, Pleural Effusion
Trial Information
Effect of the Use of a Digital Pleural Drainage System on Reducing Pleural Effusion Formation Following Lung Resection
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Overall quantity of pleural effusion (mL)
Outcome Description:
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
Outcome Time Frame:
From one hour after surgery to chest tube removal, estimated duration of 3 days
Safety Issue:
No
Principal Investigator
Yaron Shargall, MD FRCSC
Investigator Role:
Principal Investigator
Investigator Affiliation:
McMaster University
Authority:
Canada: Ethics Review Committee
Study ID:
SJHHPleuralDrainageComparsion
NCT ID:
NCT01776372
Start Date:
January 2013
Completion Date:
July 2013
Related Keywords:
- Lung Neoplasms
- Pleural Effusion
- Drainage
- Chest tubes
- Randomized Controlled Trial
- Neoplasms
- Lung Neoplasms
- Pleural Effusion
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