Clinical trial NCT01776372: Comparison of Pleural Drainage Systems on Reducing Pleural Effusion Formation Following Lung Resection
Official title: Effect of the Use of a Digital Pleural Drainage System on Reducing Pleural Effusion Formation Following Lung Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Pleural Effusion
Keywords: Drainage
Chest tubes
Randomized Controlled Trial
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Overall quantity of pleural effusion (mL)
timeFrame: From one hour after surgery to chest tube removal, estimated duration of 3 days
Secondary outcomes:
measure: Time chest tubes remain in-situ
timeFrame: An expected average of 3 days starting from transfer from OR
measure: Length of hospital stay
timeFrame: Estimated to be 4 days from admittance to discharge
measure: Mortality and Morbidity
timeFrame: 90 days of surgery
measure: Occurrence of dyspnea related to the reoccurrence of pleural effusion
timeFrame: Estimated to be 4 days from admittance to discharge
measure: Clinically significant reintervention needed
timeFrame: Estimated to be 4 days from admittance to discharge
measure: Readmission to hospital rates
timeFrame: Within 1 month of discharge
measure: Comparison of pleural fluid/plasma protein ratio and inflammatory mediators
timeFrame: Samples to be taken in OR and on days 1, 2, 3 and 4 post-surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Yaron Shargall, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: