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

April 24, 2024 updated by: Hiran Fernando, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low Suction Strategy of Chest Tube Management
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.
Other: Standard Suction Strategy of Chest Tube Management
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days from operation to chest tube removal
Time Frame: chest tube placement to chest tube removal on average up to 4 days
Days
chest tube placement to chest tube removal on average up to 4 days
Incidence of prolonged air-leak
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.
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.
Duration of hospital stay
Time Frame: Date of surgery to date of discharge (up to 5 days on average)
Days/Hours
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
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
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
Define cut-off air-leak value where prolonged air-leak is likely to occur, or standard suction strategy is preferable
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Investigators

  • Principal Investigator: Hiran Fernando, M.D., Allegheny Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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