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

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer

• Registration Number: NCT04913415
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-02
• Study Start: 2021-02-23
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of air-leak	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

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	Date of surgery to date of discharge (up to 5 days on average)	Days/Hours
Incidence of prolonged air-leak	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
Define cut-off air-leak value where prolonged air-leak is likely to occur, or standard suction strategy is preferable	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
Impact of suction strategy on patients with high Prolonged Air-Leak Score	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
Days from operation to chest tube removal	chest tube placement to chest tube removal on average up to 4 days	Days

Trial Locations

Locations (1)

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States