Clinical trial NCT04913415: A Study to Evaluate Routine Chest Tube Management After Minimally Invasive Lung Surgery
Official title: Study to Evaluate a Low Suction (LS) Versus Standard Suction (SS) Strategy for Patients Undergoing Minimally Invasive Lung Resection by VATS or Robotic Approach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to either the Low Suction or Standard Suction chest tube management group
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration of air-leak
timeFrame: 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 outcomes:
measure: Days from operation to chest tube removal
timeFrame: chest tube placement to chest tube removal on average up to 4 days
measure: Incidence of prolonged air-leak
timeFrame: 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.
measure: Duration of hospital stay
timeFrame: Date of surgery to date of discharge (up to 5 days on average)
measure: Impact of suction strategy on patients with high Prolonged Air-Leak Score
timeFrame: duration of study participation which is until chest tube is removed, duration of hospital stay, or 30 days from operation, whichever is longer
measure: Define cut-off air-leak value where prolonged air-leak is likely to occur, or standard suction strategy is preferable
timeFrame: 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
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network
name: Hiran Fernando, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayor MA, Khandhar SJ, Chandy J, Fernando HC. Implementing a thoracic enhanced recovery with ambulation after surgery program: key aspects and challenges. J Thorac Dis. 2018 Nov;10(Suppl 32):S3809-S3814. doi: 10.21037/jtd.2018.10.106.
citation: Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
citation: Cerfolio RJ, Bass C, Katholi CR. Prospective randomized trial compares suction versus water seal for air leaks. Ann Thorac Surg. 2001 May;71(5):1613-7. doi: 10.1016/s0003-4975(01)02474-2.
citation: Marshall MB, Deeb ME, Bleier JI, Kucharczuk JC, Friedberg JS, Kaiser LR, Shrager JB. Suction vs water seal after pulmonary resection: a randomized prospective study. Chest. 2002 Mar;121(3):831-5. doi: 10.1378/chest.121.3.831.
citation: Cerfolio RJ, Bryant AS. The benefits of continuous and digital air leak assessment after elective pulmonary resection: a prospective study. Ann Thorac Surg. 2008 Aug;86(2):396-401. doi: 10.1016/j.athoracsur.2008.04.016.
citation: Pompili C, Detterbeck F, Papagiannopoulos K, Sihoe A, Vachlas K, Maxfield MW, Lim HC, Brunelli A. Multicenter international randomized comparison of objective and subjective outcomes between electronic and traditional chest drainage systems. Ann Thorac Surg. 2014 Aug;98(2):490-6; discussion 496-7. doi: 10.1016/j.athoracsur.2014.03.043. Epub 2014 Jun 4.
citation: Brunelli A, Salati M, Pompili C, Refai M, Sabbatini A. Regulated tailored suction vs regulated seal: a prospective randomized trial on air leak duration. Eur J Cardiothorac Surg. 2013 May;43(5):899-904. doi: 10.1093/ejcts/ezs518. Epub 2012 Sep 28.
citation: Lijkendijk M, Licht PB, Neckelmann K. The Influence of Suction on Chest Drain Duration After Lobectomy Using Electronic Chest Drainage. Ann Thorac Surg. 2019 Jun;107(6):1621-1625. doi: 10.1016/j.athoracsur.2018.12.059. Epub 2019 Feb 8.
citation: Holbek BL, Christensen M, Hansen HJ, Kehlet H, Petersen RH. The effects of low suction on digital drainage devices after lobectomy using video-assisted thoracoscopic surgery: a randomized controlled trialdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):673-681. doi: 10.1093/ejcts/ezy361.