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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04913415
• Other study ID #: 2021-005
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Other:
• Low 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.
• Standard 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.

Locations

Country	Name	City	State
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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 — View 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. — View 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. — View 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. — View 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):6 — View 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. — View 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. — View 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. — View 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 Su — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days from operation to chest tube removal	Days	chest tube placement to chest tube removal on average up to 4 days
Secondary	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.
Secondary	Duration of hospital stay	Days/Hours	Date of surgery to date of discharge (up to 5 days on average)
Secondary	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
Secondary	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