Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection (NOTUBE)

Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Status and phase: Unknown; Phase 3

Conditions: Lung Diseases, Interstitial; Pulmonary Nodule, Solitary

Treatments: Procedure: Do not leave a chest tube in the pleural cavity.; Procedure: Do leave a chest tube in the pleural cavity.

Study type: Interventional

Funder types: Other

Identifiers

NCT00841750

9009001

Details and patient eligibility

About

After performing VATS pulmonary wedge resections, a chest tube is routinely left in the pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has no scientific foundations. The investigators believe it is possible to avoid the placement of a chest tube after this procedure in a great amount of patients. This is a randomized controlled clinical trial with analysis blinding in which the investigators want to compare the outcomes between installing a chest tube or not after VATS pulmonary wedge resections. The investigators will include consecutively patients with interstitial lung disease or indeterminate pulmonary nodules undergoing this procedure, at the participating institutions. The investigators calculated a sample size of 50 subjects in each group using pneumothorax < 10% data from Luckraz et al and to determine a difference of hospital stay of 2 versus 1 day; DS(1.5), power = 0.9 and alpha = 0.05.

Enrollment: 100 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing video-assisted thoracoscopic surgery pulmonary wedge resections at the participating institutions.
• No evidence of air leak at the end of the surgical procedure.
• No active bleeding at the end of the surgical procedure.

Exclusion criteria

• Pleural effusion previous to the procedure requiring drainage after it.
• Bullous or emphysematous changes in lung parenchyma.
• Patients going to positive pressure in the airways after the procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

No chest tube

Experimental group

Description:

No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.

Treatment:

Procedure: Do not leave a chest tube in the pleural cavity.

Chest tube

Active Comparator group

Description:

Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.

Treatment:

Procedure: Do leave a chest tube in the pleural cavity.