Primary Spontaneous PneumothoraxNCT04831554
Which is Better Between Single Chest Tube and Multiple Tubes Drainage in Primary Spontaneous Pneumothorax
A study testing single chest tube drainage in people with Primary Spontaneous Pneumothorax, run by Peking University Third Hospital.
Trial summary
There was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Primary Spontaneous Pneumothorax
- What is being tested?
- single chest tube drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed by chest radiograph or CT as primary spontaneous pneumothorax
- Underwent bullectomy and pleurodesis
- Postoperative indwelling chest tubes
Who cannot join
- Secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax
- Previous surgery history
- People with severe comorbidities
About this study
Official title: Comparison of the Efficacy of Single Tube Versus Multiple Tubes Drainage After Bullectomy and Pleurodesis for Primary Spontaneous Pneumothorax
There was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis. After routine procedure the participants will randomized to either placed single chest tube or multiple chest tubes
Read the detailed description
Primary spontaneous pneumothorax (PSP) occurs after the rupture of small bullae or a subpleural bleb in otherwise normal lungs. The indications for surgical treatment include persistent air leak after intercostal tube drainage, recurrent PSP, and contralateral PSP. The video-assisted thoracoscopic surgery (VATS) approach probably represents the treatment of choice for PSP.
The presence of a residual pleural space after surgery may be a factor associated with increased risk of recurrence. One possible hypothesis to explain the association between residual pleural space and recurrence of pneumothorax may be the failed pleurodesis due to lack of pleura-pleura apposition. Multiple chest tubes are effective in clinical practice, but there was no convinctive evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis. This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis.After routine procedure the participants will randomized to either placed multiple chest tubes or single chest tube.
The recurrence of the two group and other postoperative clinical parameters will be observed.
- Conditions
- Primary Spontaneous Pneumothorax
- Being tested
- single chest tube drainage
- Keywords
- number of chest tube, Bullectomy, Pleurodesis, Primary Spontaneous Pneumothorax
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single chest tube drainageProcedure or surgery
place single chest tube after surgery of PSP
| Study group | Role | What they receive |
|---|---|---|
| single chest tube group | Experimental | Not described Receives: Procedure: single chest tube drainage |
| multiple chest tubes group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
Recurrence of pneumothorax during 2 years follow-up
Measured: 2 years after operation
Secondary outcomes (1)
complications
post-operation complications，such as air leakage
Measured: 30days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start31 Oct 2021 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831554
- Sponsor's protocol ID
- mashaohua1976-4
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang L, Jiang G, Zhu Y, Hao W, Zhang L. Risk factors predisposing to prolonged air leak after video-assisted thoracoscopic surgery for spontaneous pneumothorax. Ann Thorac Surg. 2014 Mar;97(3):1008-13. doi: 10.1016/j.athoracsur.2013.10.031. Epub 2013 Dec 25.
PubMed 24370202Sudduth CL, Shinnick JK, Geng Z, McCracken CE, Clifton MS, Raval MV. Optimal surgical technique in spontaneous pneumothorax: a systematic review and meta-analysis. J Surg Res. 2017 Apr;210:32-46. doi: 10.1016/j.jss.2016.10.024. Epub 2016 Nov 3.
PubMed 28457339
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Single Tube Versus Multiple Tubes Drainage After Bullectomy and Pleurodesis for Primary Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT04831554
- Acronym / sponsor ID
- mashaohua1976-4
- Conditions
- Primary Spontaneous Pneumothorax
- Keywords
- number of chest tube, Bullectomy, Pleurodesis, Primary Spontaneous Pneumothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 31 Oct 2021 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 5 Apr 2021 (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.
There was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis. After routine procedure the participants will randomized to either placed single chest tube or multiple chest tubes
Detailed description
Primary spontaneous pneumothorax (PSP) occurs after the rupture of small bullae or a subpleural bleb in otherwise normal lungs. The indications for surgical treatment include persistent air leak after intercostal tube drainage, recurrent PSP, and contralateral PSP. The video-assisted thoracoscopic surgery (VATS) approach probably represents the treatment of choice for PSP.
The presence of a residual pleural space after surgery may be a factor associated with increased risk of recurrence. One possible hypothesis to explain the association between residual pleural space and recurrence of pneumothorax may be the failed pleurodesis due to lack of pleura-pleura apposition. Multiple chest tubes are effective in clinical practice, but there was no convinctive evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis. This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis.After routine procedure the participants will randomized to either placed multiple chest tubes or single chest tube.
The recurrence of the two group and other postoperative clinical parameters will be observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single chest tube group | Experimental | Procedure: single chest tube drainage |
| multiple chest tubes group | No intervention | – |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosed by chest radiograph or CT as primary spontaneous pneumothorax
- Underwent bullectomy and pleurodesis
- Postoperative indwelling chest tubes
Key exclusion criteria (3 listed)
- Secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax
- Previous surgery history
- People with severe comorbidities
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 |
|---|---|---|
| single chest tube drainageplace single chest tube after surgery of PSP | Procedure or surgery | single chest tube group |
Primary outcome
recurrence
Time frame: 2 years after operation
Recurrence of pneumothorax during 2 years follow-up
1 secondary outcome
complications
Time frame: 30days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Background: PubMed 24370202Jiang L, Jiang G, Zhu Y, Hao W, Zhang L. Risk factors predisposing to prolonged air leak after video-assisted thoracoscopic surgery for spontaneous pneumothorax. Ann Thorac Surg. 2014 Mar;97(3):1008-13. doi: 10.1016/j.athoracsur.2013.10.031. Epub 2013 Dec 25.
- Background: PubMed 28457339Sudduth CL, Shinnick JK, Geng Z, McCracken CE, Clifton MS, Raval MV. Optimal surgical technique in spontaneous pneumothorax: a systematic review and meta-analysis. J Surg Res. 2017 Apr;210:32-46. doi: 10.1016/j.jss.2016.10.024. Epub 2016 Nov 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing single chest tube drainage in people with Primary Spontaneous Pneumothorax, run by Peking University Third Hospital.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: 2 years after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831554, which also lists 2 linked publications.
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 18 Oct 2021.