Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2023
CompletedFirst Submitted
Initial submission to the registry
April 8, 2024
CompletedFirst Posted
Study publicly available on registry
May 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedMay 16, 2025
January 1, 2025
2.2 years
April 8, 2024
May 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence of Pneumothorax
2 years from surgery
Secondary Outcomes (5)
Postoperative Length of Stay
End of Surgery to Discharge, up to 90 days
Total length of stay
Admission to Discharge, up to 90 days
Chest Tube Duration
End of surgery to removal of chest tube, up to 90 days
Complications
2 years from surgery
Need for interventions
2 years from surgery
Study Arms (2)
Early Chest Tube Removal
EXPERIMENTALSubjects within the "Early Removal" group will have their chest tube removed on POD#1 within 24 hours from the end of the surgery.
Standard Chest Tube Removal
ACTIVE COMPARATORSubjects in the "Standard Removal" group will have their chest tube kept to suction on POD#1 with removal on POD#2.
Interventions
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
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
A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.
Eligibility Criteria
You may qualify if:
- Patient undergoing video assisted thoracoscopic surgery with blebectomy/wedge resection and chemical pleurodesis for primary spontaneous pneumothorax
- Adult patients (\> 18 years)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swedish Cancer Institute
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2024
First Posted
May 13, 2024
Study Start
October 3, 2023
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2027
Last Updated
May 16, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share
No plan to share IPD