Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial

Conditions

• Primary Spontaneous Pneumothorax

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Early Chest Tube Removal — PROCEDURE
  Subjects within the "Early Removal" group will have their chest tube removed if the following criteria are met on the morning of POD#1: * ≤1 cm of apical pleural separation and no other areas of pleural separation * No air leak * No bloody output or concern for bleeding * \< 400cc of drainage
• Standard Chest Tube Removal — PROCEDURE
  Subjects within the "Standard Removal" group will have their chest tube removal on POD#2 if the following criteria are met on the morning of POD#1: * ≤1 cm of apical pleural separation and no other areas of pleural separation * No air leak * No bloody output or concern for bleeding * \< 400cc of drainage
• Apical Chest Tube — DEVICE
  A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.

Study Details

Video-assisted thoracoscopic surgery (VATS) with blebectomy/wedge resection plus pleurodesis is the standard of care for recurrent primary spontaneous pneumothorax (PSP) or, in certain instances, after the first episode. The chest tube from surgery is typically kept to suction until post-operative day (POD) 2 to allow for scarring of the lung to the chest to prevent recurrence. However, the scarring process takes place over a period of weeks and is there no data to support POD#2 as the best time to remove the chest tube. Also, shorter chest tube duration can lower length of stay, patient discomfort, and hospital cost. The goal of this randomized study is to determine if early removal (POD#1) of chest tube after video-assisted thoracoscopic surgery (VATS) with blebectomy/wedge resection plus chemical pleurodesis for primary spontaneous pneumothorax (PSP): * has no worse 2-year recurrence rate compared to standard removal (POD#2) * will lower length of stay compared to standard removal * will result in less complications or re-interventions compared to standard removal Participants will be asked to join prior to surgery. Following standard-of-care surgery, participants will be screened for randomization. If still eligible, participants will be randomized for early chest tube removal or standard removal. Early Removal will happen within 24 hours after surgery, with Standard Removal happening day 2 after surgery. Participants will follow-up with the study team for 2 years on the following schedule: * In clinic with a chest x-ray 2 weeks after surgery * By phone 3 months after surgery * In clinic with a chest x-ray 1 year after surgery * In clinic with a chest x-ray 2 years after surgery

Key Dates

Start date

Oct 3, 2023

Status verified

Jan 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2027

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Early Chest Tube Removal
  Subjects within the "Early Removal" group will have their chest tube removed on POD#1 within 24 hours from the end of the surgery.
• Active Comparator: Standard Chest Tube Removal
  Subjects in the "Standard Removal" group will have their chest tube kept to suction on POD#1 with removal on POD#2.

Primary Outcome Measure

Recurrence of Pneumothorax [ Time Frame: 2 years from surgery ]

Central Contacts

• Brian Louie, M.D.
  206-215-6800
  [email protected]
• John Campbell, M.D.
  206-215-6800
  [email protected]

Locations (1)

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