Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial
NCT ID: NCT06411431
Last Updated: 2025-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-10-03
2027-12-31
Brief Summary
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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
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Detailed Description
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Subjects will undergo VATS with resection of all visible disease or an apical wedge resection if none is found. The use of reinforced or non-reinforced staple loads is left to surgeons' preference. For pleurodesis, choice of chemical agent is at the desecration of the surgeon and common practice but limited to 3 agents (talc, dextrose, or a tetracycline antibiotic). Surgeons can choose to perform a mechanical pleurodesis as they deem appropriate. A single apical chest tube will be placed and connected to a suction device set to at least -20 mmHg of suction. Subjects will then be admitted overnight.
Subjects will be re-evaluated on the morning of POD#1. Those without an air leak, with \<400 cc of non-bloody chest tube output, and having a maximum 1cm of apical pleural separation (as determined by the surgeon) will be eligible for randomization to either early or standard removal of their chest tube.
Randomization will occur in a 1:1 manner, stratified by participating center. Subjects within the "Early Removal" group will have their chest tube removed on postoperative day 1 within 24 hours from the end of the surgery with a follow-up chest x-ray within 6 hours from removal in addition to monitoring of symptoms. If the subject remains stable without developing symptoms (new oxygen requirement, shortness of breath, etc.) or increased pleural separation on x-ray, they will be eligible for discharge with appropriate follow-up.
Subjects in the "Standard Removal" group will keep their chest tube to suction until postoperative day 2. The chest tube would be removed on POD#2 with a follow up chest x-ray within 6 hours. If the subject remains stable without developing symptoms (new oxygen requirement, shortness of breath, etc.) or growth of pleural separation on chest x-ray, they would be eligible for discharge.
Subjects will then follow up in clinic within 2 weeks of the operation with a chest x-ray. A 3-month follow-up phone call will be performed. At 1-year post-operative, subjects again will have standard clinic follow up and chest x-ray. Finally, a 2 year follow up phone call and chest x-ray will be completed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Subjects within the "Early Removal" group will have their chest tube removed on POD#1, within 24 hours from the end of the surgery.
* Subjects in the "Standard Removal" group will have their chest tube would be removed on POD#2.
TREATMENT
NONE
Study Groups
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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.
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
Apical Chest Tube
A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Adult patients (\> 18 years)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Swedish Medical Center
OTHER
Responsible Party
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Locations
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Swedish Cancer Institute
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PSP-RCT
Identifier Type: -
Identifier Source: org_study_id
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