Lung Cancer
Conditions
Brief summary
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.
Interventions
OTHERLow Suction Strategy of Chest Tube Management
A digital chest tube will be set to a low pressure mode (-8mmHg) during recovery after minimally invasive lung resection.
OTHERStandard Suction Strategy of Chest Tube Management
A digital chest tube will be to the standard suction mode (-20mmHg) during recovery after minimally invasive lung resection.
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will be randomized to either the Low Suction or Standard Suction chest tube management group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who are undergoing lobectomy or segmentectomy 2. Patients undergoing wedge resection to diagnose, or as definitive therapy for a lung nodule/cancer. 3. Able to understand and sign consent
Exclusion criteria
1. Patients undergoing pneumonectomy or bilobectomy 2. Patients undergoing resection for inflammatory conditions such as aspergillosis 3. Patients undergoing diagnostic wedge resection for interstitial lung disease 4. Patients undergoing redo-VATS or thoracotomy on the same side as current planned resection 5. Patients found to have a frozen chest at the time of surgery, requiring extensive adhesiolysis, 6. Patients who are discovered to have metastatic disease during the operation, so that resection is no longer indicated. 7. Patients where a clinical decision to place more than one chest-tube is made
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of air-leak | 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) | Days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Define cut-off air-leak value where prolonged air-leak is likely to occur, or standard suction strategy is preferable | 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 | mL/minute |
| Days from operation to chest tube removal | chest tube placement to chest tube removal on average up to 4 days | Days |
| Incidence of prolonged air-leak | 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. | Rate of subjects who experience an air-leak which lasts for 5 or more days |
| Duration of hospital stay | Date of surgery to date of discharge (up to 5 days on average) | Days/Hours |
| Impact of suction strategy on patients with high Prolonged Air-Leak Score | duration of study participation which is until chest tube is removed, duration of hospital stay, or 30 days from operation, whichever is longer | Incidence of PAL based suction strategy |
Countries
United States
Outcome results
None listed