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Lung CancerNCT04913415

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

A study testing Low Suction Strategy of Chest Tube Management and Standard Suction Strategy of Chest Tube Management in people with Lung Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Low Suction Strategy of Chest Tube Management and Standard Suction Strategy of Chest Tube Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
23 Feb 2021to Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

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

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
Being tested
Low Suction Strategy of Chest Tube Management, Standard Suction Strategy of Chest Tube Management
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Suction Strategy of Chest Tube ManagementOther

    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 ManagementOther

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

Study groups in NCT04913415
Study groupRoleWhat they receive
Low Suction Strategy of Chest Tube ManagementOtherNot described
Receives: Other: Low Suction Strategy of Chest Tube Management
Standard Suction Strategy of Chest Tube ManagementOtherNot described
Receives: Other: Standard Suction Strategy of Chest Tube Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of air-leak

    Days

    Measured: 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)

  1. Days from operation to chest tube removal

    Days

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start23 Feb 2021
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized to either the Low Suction or Standard Suction chest tube management group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04913415
Sponsor's protocol ID
2021-005
Status last verified
Apr 2024
First submitted
2 Feb 2021
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Low Suction Strategy of Chest Tube Management and Standard Suction Strategy of Chest Tube Management in people with Lung Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of air-leak (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04913415, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.

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