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

A

Allegheny Health Network (AHN)

Status

Active, not recruiting

Conditions

Lung Cancer

Treatments

Other: Low Suction Strategy of Chest Tube Management
Other: Standard Suction Strategy of Chest Tube Management

Study type

Interventional

Funder types

Other

Identifiers

NCT04913415
2021-005

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Low Suction Strategy of Chest Tube Management
Other group
Treatment:
Other: Low Suction Strategy of Chest Tube Management
Standard Suction Strategy of Chest Tube Management
Other group
Treatment:
Other: Standard Suction Strategy of Chest Tube Management

Trial contacts and locations

1

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Central trial contact

Michael Paskewicz, M.A.; Hiran Fernando, M.D.

Data sourced from clinicaltrials.gov

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