Recruiting

Chest Tube Removal

Sponsor:

Swedish Medical Center

Code:

NCT06411431

Conditions

Primary Spontaneous Pneumothorax

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early Chest Tube Removal

Standard Chest Tube Removal

Apical Chest Tube

Study Details

Brief summary:

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

Conditions

Primary Spontaneous Pneumothorax

Study ID

NCT06411431

Start date

Oct 3, 2023

Status verified date

Jan, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient undergoing video assisted thoracoscopic surgery with blebectomy/wedge resection and chemical pleurodesis for primary spontaneous pneumothorax
  • Adult patients (> 18 years)

Exclusion Criteria:

  • Subjects with history of chest radiation or prior ipsilateral chest surgery
  • Tuberculosis or other infectious etiology
  • Secondary spontaneous pneumothorax (COPD, cancer, cystic fibrosis, connective tissue disease, sarcoidosis, catamenial, etc.)
  • Pneumothorax due to trauma
  • Hemothorax or hydropneumothorax
  • Immunocompromised subjects: neutropenic, leukopenia, or subjects taking immunosuppressive medication such as chemotherapy, transplant medications, steroid (≥5 mg of prednisone or equivalent), etc.
  • Interstitial lung disease
  • Children (<18)
  • Pregnant women
  • Adults unable to consent for themselves
  • Prisoners

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Early Chest Tube Removal

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

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

A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

Contacts

More Information

Sponsor

Swedish Medical Center

Last update posted

May 16, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Swedish Medical Center on 2025-05-16.