A Study to Evaluate Routine Chest Tube Management After Minimally Invasive Lung Surgery

Study Overview
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Brief Summary
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Chest tubes are routinely required after surgical procedures for lung cancer. This device is a flexible plastic tube that is inserted through the chest wall to remove air or fluid from around your lungs after surgery for lung cancer. There are two general strategies associated with the clinical management of chest tubes, active and passive suction. If suction is compared to driving a car, active suction is similar to pressing the gas pedal while passive suction is like letting your car move on its own. The suction approach taken by surgeons largely depends on how they were trained and some personal biases and beliefs. However there is no general consensus about which chest tube management strategy is best. This research aims to compare two settings on a digital drainage system, a low suction (LS) mode - passive suction - and standard suction (ss) mode - active suction. From the data collected, the researchers will analyze whether LS or SS will lead to a better recovery after surgery.

Official Title
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Study to Evaluate a Low Suction (LS) Versus Standard Suction (SS) Strategy for Patients Undergoing Minimally Invasive Lung Resection by VATS or Robotic Approach

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Low Suction Strategy of Chest Tube Management
* Other: Standard Suction Strategy of Chest Tube Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are undergoing lobectomy or segmentectomy Patients undergoing wedge resection to diagnose, or as definitive therapy for a lung nodule/cancer. Able to understand and sign consent Exclusion Criteria: Patients undergoing pneumonectomy or bilobectomy Patients undergoing resection for inflammatory conditions such as aspergillosis Patients undergoing diagnostic wedge resection for interstitial lung disease Patients undergoing redo-VATS or thoracotomy on the same side as current planned resection Patients found to have a frozen chest at the time of surgery, requiring extensive adhesiolysis, Patients who are discovered to have metastatic disease during the operation, so that resection is no longer indicated. Patients where a clinical decision to place more than one chest-tube is made

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to either the Low Suction or Standard Suction chest tube management group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low Suction Strategy of Chest Tube Management<br> | Other: Low Suction Strategy of Chest Tube Management<br>* A digital chest tube will be set to a low pressure mode (-8mmHg) during recovery after minimally invasive lung resection.<br>|
| Other: Standard Suction Strategy of Chest Tube Management<br> | Other: Standard Suction Strategy of Chest Tube Management<br>* A digital chest tube will be to the standard suction mode (-20mmHg) during recovery after minimally invasive lung resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of air-leak | Days | When the subject arrives to the recovery room directly after surgery, then every 24 hours while admitted to the hospital until air leak resolves (on average, up to 4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days from operation to chest tube removal | Days | chest tube placement to chest tube removal on average up to 4 days | 
| Incidence of prolonged air-leak | Rate of subjects who experience an air-leak which lasts for 5 or more days | Categorial variable: Present or not. Determination of category is measured from onset of air-leak to air-leak resolution or 5 days, whichever comes first. | 
| Duration of hospital stay | Days/Hours | Date of surgery to date of discharge (up to 5 days on average) | 
| Impact of suction strategy on patients with high Prolonged Air-Leak Score | Incidence of PAL based suction strategy | duration of study participation which is until chest tube is removed, duration of hospital stay, or 30 days from operation, whichever is longer | 
| Define cut-off air-leak value where prolonged air-leak is likely to occur, or standard suction strategy is preferable | mL/minute | duration of study participation, which is until the chest-tube is removed, duration of initial hospital stay, or 30 days from operation, whichever is longer |