Primary Spontaneous PneumothoraxNCT06411431
Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial
A study testing Early Chest Tube Removal, Standard Chest Tube Removal and Apical Chest Tube in people with Primary Spontaneous Pneumothorax, run by Swedish Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Spontaneous Pneumothorax
- What is being tested?
- Early Chest Tube Removal, Standard Chest Tube Removal and Apical Chest Tube
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing video assisted thoracoscopic surgery with blebectomy/wedge resection and chemical pleurodesis for primary spontaneous pneumothorax
- Adult patients (> 18 years)
Who cannot join
- 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.
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- Interstitial lung disease
- Children (<18)
- Pregnant women
- Adults unable to consent for themselves
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
Brian Louie, M.D., 206-215-6800, brian.louie@swedish.org
John Campbell, M.D., 206-215-6800, john.campbell@swedish.org
About this study
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):
Read more
- 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
Read the detailed description
This study will be a multicentered randomized controlled trial. The trial will recruit all adult subjects (>18 years old) with PSP who are undergoing VATS blebectomy/wedge resection with chemical pleurodesis from participating centers. Subjects will be identified by the surgical team when evaluating a subject with PSP for surgery. If screened eligible and not meeting an exclusion criterion, the trial will be discussed with them, and consent will be obtained.
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
- Primary Spontaneous Pneumothorax
- Being tested
- Early Chest Tube Removal, Standard Chest Tube Removal, Apical Chest Tube
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Chest Tube RemovalProcedure or surgery
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 RemovalProcedure or surgery
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 TubeDevice
A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Early Chest Tube Removal; Device: Apical Chest Tube |
| 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. Receives: Procedure: Standard Chest Tube Removal; Device: Apical Chest Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Pneumothorax
Measured: 2 years from surgery
Secondary outcomes (5)
Postoperative Length of Stay
Postoperative length of stay is defined from the end of the operation until discharge.
Measured: End of Surgery to Discharge, up to 90 days
Total length of stay
Total length of stay is defined as the time from admission until time subject is discharged.
Measured: Admission to Discharge, up to 90 days
Chest Tube Duration
From the end of the operation until the removal of the chest tube placed at the initial VATS with pleurodesis.
Measured: End of surgery to removal of chest tube, up to 90 days
Complications
Complications post-surgery such as pleural separation, pleural effusion, hemothorax, etc.
Measured: 2 years from surgery
Need for interventions
Need for additional interventions post-surgery such as thoracentesis, chest tube placement, etc.
Measured: 2 years from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start3 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Spontaneous PneumothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Surgical intervention and related care will follow current standard practices with the following items representing the randomized arms under investigation: * 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411431
- Sponsor's protocol ID
- PSP-RCT
- Status last verified
- Jan 2025
- First submitted
- 8 Apr 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06411431
- Acronym / sponsor ID
- PSP-RCT
- Conditions
- Primary Spontaneous Pneumothorax
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This study will be a multicentered randomized controlled trial. The trial will recruit all adult subjects (>18 years old) with PSP who are undergoing VATS blebectomy/wedge resection with chemical pleurodesis from participating centers. Subjects will be identified by the surgical team when evaluating a subject with PSP for surgery. If screened eligible and not meeting an exclusion criterion, the trial will be discussed with them, and consent will be obtained.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Surgical intervention and related care will follow current standard practices with the following items representing the randomized arms under investigation: * 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.
| Arm | Type | Receives |
|---|---|---|
| Early Chest Tube Removal | Experimental | Procedure: Early Chest Tube Removal, Device: Apical Chest TubeSubjects 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 comparator | Procedure: Standard Chest Tube Removal, Device: Apical Chest TubeSubjects in the "Standard Removal" group will have their chest tube kept to suction on POD#1 with removal on POD#2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing video assisted thoracoscopic surgery with blebectomy/wedge resection and chemical pleurodesis for primary spontaneous pneumothorax
- Adult patients (> 18 years)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Chest Tube RemovalSubjects 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 | Procedure or surgery | Early Chest Tube Removal |
| Standard Chest Tube RemovalSubjects 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 | Procedure or surgery | Standard Chest Tube Removal |
| Apical Chest TubeA single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction. | Device | Early Chest Tube Removal, Standard Chest Tube Removal |
Primary outcome
Recurrence of Pneumothorax
Time frame: 2 years from surgery
5 secondary outcomes
Postoperative Length of Stay
Time frame: End of Surgery to Discharge, up to 90 days
Total length of stay
Time frame: Admission to Discharge, up to 90 days
Chest Tube Duration
Time frame: End of surgery to removal of chest tube, up to 90 days
Complications
Time frame: 2 years from surgery
Need for interventions
Time frame: 2 years from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Chest Tube Removal, Standard Chest Tube Removal and Apical Chest Tube in people with Primary Spontaneous Pneumothorax, run by Swedish Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Louie, M.D. (206-215-6800, brian.louie@swedish.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Pneumothorax (time frame: 2 years from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.