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Status unknownNCT04913415Updated Apr 25, 2024

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

An interventional study of Low Suction Strategy of Chest Tube Management and Standard Suction Strategy of Chest Tube Management in Lung Cancer, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.

Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.

This study's planned enrollment of 160 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) is the lead sponsor of 47 studies on the registry; 18 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Other
    Low Suction Strategy of Chest Tube Management

    Other: Low Suction Strategy of Chest Tube Management

  • Other
    Standard Suction Strategy of Chest Tube Management

    Other: Standard Suction Strategy of Chest Tube Management

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.

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What researchers measure

Primary outcomes

  1. Duration of air-leak

    Days

    Time frame: 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

  1. Days from operation to chest tube removal

    Days

    Time frame: chest tube placement to chest tube removal on average up to 4 days

  2. Incidence of prolonged air-leak

    Rate of subjects who experience an air-leak which lasts for 5 or more days

    Time frame: 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.

  3. Duration of hospital stay

    Days/Hours

    Time frame: Date of surgery to date of discharge (up to 5 days on average)

  4. Impact of suction strategy on patients with high Prolonged Air-Leak Score

    Incidence of PAL based suction strategy

    Time frame: duration of study participation which is until chest tube is removed, duration of hospital stay, or 30 days from operation, whichever is longer

  5. Define cut-off air-leak value where prolonged air-leak is likely to occur, or standard suction strategy is preferable

    mL/minute

    Time frame: 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

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Study locations

1 site
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
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References and documents

Publications

  • 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. PubMed 30505568 ↗
  • 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. PubMed 30304509 ↗
  • 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. PubMed 11383809 ↗
  • 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. PubMed 11888968 ↗
  • 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. PubMed 18640304 ↗
  • 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. PubMed 24906602 ↗
  • 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. PubMed 23024236 ↗
  • 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. PubMed 30742815 ↗
  • 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. PubMed 30445572 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04913415
Lead sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Responsible party
Hiran Fernando, MD (Chief of Thoracic Surgery at Allegheny General Hospital, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)) — Principal investigator
First posted
Jun 4, 2021
Start date
Feb 23, 2021
Primary completion
Aug 2024 (estimated)
Completion
Aug 2024 (estimated)
Last update
Apr 25, 2024

Study contacts

Hiran Fernando, M.D.
principal investigator · Allegheny Health Network

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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