[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547704":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Swedish Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Chest Tube Removal","EXPERIMENTAL","Subjects within the \"Early Removal\" group will have their chest tube removed on POD#1 within 24 hours from the end of the surgery.",[13,14],"Procedure: Early Chest Tube Removal","Device: Apical Chest Tube",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Chest Tube Removal","ACTIVE_COMPARATOR","Subjects in the \"Standard Removal\" group will have their chest tube kept to suction on POD#1 with removal on POD#2.",[20,14],"Procedure: Standard Chest Tube Removal",[22,27,30],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"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:\n\n* ≤1 cm of apical pleural separation and no other areas of pleural separation\n* No air leak\n* No bloody output or concern for bleeding\n* \\\u003C 400cc of drainage",[9],null,{"type":23,"name":16,"description":28,"armGroupLabels":29,"otherNames":26},"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:\n\n* ≤1 cm of apical pleural separation and no other areas of pleural separation\n* No air leak\n* No bloody output or concern for bleeding\n* \\\u003C 400cc of drainage",[16],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"DEVICE","Apical Chest Tube","A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.",[9,16],[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Brian Louie, M.D.","CONTACT","206-215-6800","brian.louie@swedish.org",{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},"John Campbell, M.D.","john.campbell@swedish.org",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Swedish Cancer Institute","RECRUITING","Seattle","Washington","98104","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-122.33207,47.60621,{"lat":57,"lon":56},[60,61],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":39,"phoneExt":26,"email":43},{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100547704","early-chest-tube-removal-after-surgery-for-primary-spontaneous-pneumothorax-a-randomized-controlled-trial-100547704",false,"NCT06411431","Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patient undergoing video assisted thoracoscopic surgery with blebectomy\u002Fwedge resection and chemical pleurodesis for primary spontaneous pneumothorax\n* Adult patients (\\> 18 years)\n\nExclusion Criteria:\n\n* Subjects with history of chest radiation or prior ipsilateral chest surgery\n* Tuberculosis or other infectious etiology\n* Secondary spontaneous pneumothorax (COPD, cancer, cystic fibrosis, connective tissue disease, sarcoidosis, catamenial, etc.)\n* Pneumothorax due to trauma\n* Hemothorax or hydropneumothorax\n* Immunocompromised subjects: neutropenic, leukopenia, or subjects taking immunosuppressive medication such as chemotherapy, transplant medications, steroid (≥5 mg of prednisone or equivalent), etc.\n* Interstitial lung disease\n* Children (\\\u003C18)\n* Pregnant women\n* Adults unable to consent for themselves\n* Prisoners","ALL","18 Years",{"count":73,"type":74},200,"ESTIMATED","INTERVENTIONAL",[77],"NA","Video-assisted thoracoscopic surgery (VATS) with blebectomy\u002Fwedge 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.\n\nThe goal of this randomized study is to determine if early removal (POD#1) of chest tube after video-assisted thoracoscopic surgery (VATS) with blebectomy\u002Fwedge resection plus chemical pleurodesis for primary spontaneous pneumothorax (PSP):\n\n* has no worse 2-year recurrence rate compared to standard removal (POD#2)\n* will lower length of stay compared to standard removal\n* will result in less complications or re-interventions compared to standard removal\n\nParticipants 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.\n\nParticipants will follow-up with the study team for 2 years on the following schedule:\n\n* In clinic with a chest x-ray 2 weeks after surgery\n* By phone 3 months after surgery\n* In clinic with a chest x-ray 1 year after surgery\n* In clinic with a chest x-ray 2 years after surgery",[80],"Primary Spontaneous Pneumothorax","2025-05-13",{"date":83,"type":84},"2025-05-16","ACTUAL",{"date":86,"type":84},"2023-10-03",{"date":88,"type":74},"2027-12",{"name":5,"class":6},1]