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

NCT04913415 | Active Not Recruiting

• 1 other identifier: 2021-005
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Days from operation to chest tube removal

  chest tube placement to chest tube removal on average up to 4 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.

• Duration of hospital stay

  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

  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

  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

Study Arms (2)

Low Suction Strategy of Chest Tube Management

OTHER

Other: Low Suction Strategy of Chest Tube Management

Standard Suction Strategy of Chest Tube Management

OTHER

Other: Standard Suction Strategy of Chest Tube Management

Interventions

Low Suction Strategy of Chest Tube Management OTHER

A digital chest tube will be set to a low pressure mode (-8mmHg) during recovery after minimally invasive lung resection.

Low Suction Strategy of Chest Tube Management

Standard Suction Strategy of Chest Tube Management OTHER

A digital chest tube will be to the standard suction mode (-20mmHg) during recovery after minimally invasive lung resection.

Standard Suction Strategy of Chest Tube Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (9)

• 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.

  PMID: 30505568 RESULT

• 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.

  PMID: 30304509 RESULT

• 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.

  PMID: 11383809 RESULT

• 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.

  PMID: 11888968 RESULT

• 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.

  PMID: 18640304 RESULT

• 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.

  PMID: 24906602 RESULT

• 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.

  PMID: 23024236 RESULT

• 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.

  PMID: 30742815 RESULT

• 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.

  PMID: 30445572 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hiran Fernando, M.D.

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Surgery at Allegheny General Hospital

Model Details: Subjects will be randomized to either the Low Suction or Standard Suction chest tube management group

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: June 4, 2021
• Study Start: February 23, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

US (1)