PneumothoraxpneumothoraxNCT00556335
Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
A study testing manual aspiration and conventional drainage in people with Pneumothorax, run by Isala at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the efficacy of manual aspiration in comparison to conventional chest tube drainage in pneumothorax therapy: 1. whether manual aspiration will shorten hospital admission. 2. whether the lung will expand by means of clinical and radiological findings. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- manual aspiration and conventional drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2007to Apr 2011
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with a first episode of a symptomatic pneumothorax admitted to the ER of the hospital (spontaneous or traumatic) or
- patients with an asymptomatic pneumothorax with a size of ≥ 20 % as estimated by Light's formula
- age ≥ 18 and < 85 years
- smoking is tolerated
Who cannot join
- recurrent pneumothorax
- lung fibrosis
- patients with (lung) cancer
- pregnant women
- comorbidity limiting decision making (psychiatric disease, alcohol or drug abuse)
- prior randomisation
Show all 10Show fewer
- Marfan syndrome
- COPD patients
- tension pneumothorax
- multitrauma patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomised Trial in Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
The purpose of this study is to evaluate the efficacy of manual aspiration in comparison to conventional chest tube drainage in pneumothorax therapy:
- whether manual aspiration will shorten hospital admission.
- whether the lung will expand by means of clinical and radiological findings.
Read the detailed description
No consensus has been defined concerning the exact treatment of a first episode of SP. Literature suggests similar immediate and long-term efficacy of manual aspiration and chest tube drainage. Morbidity of manual aspiration is low and the procedure is well tolerated. Manual aspiration is safe with a complication rate of only 1 % and can be performed in the outpatient clinic in the majority of patients reducing costs. Our aim is to re - evaluate these findings with a mono-centre study with 114 patients, set-up for the first time in the Netherlands with an expectancy to confirm the former findings.
Aim of the study:
To evaluate the efficacy of manual aspiration in comparison to conventional chest tube drainage in pneumothorax therapy:
- whether manual aspiration will shorten hospital admission.
- whether the lung will expand by means of clinical and radiological findings.
Study design: prospective single-centre, open randomised trial.
Randomisation:
With a computer minimization program for manual aspiration or usual care with special attendance to the cause of pneumothorax (spontaneous or traumatic), the presence of smoking and gender.
Statistical analysis:
Our primary aim is to demonstrate a higher efficacy for manual aspiration in terms of a shorter admission duration (LOS) in favor of manual aspiration with similar therapy success rates. We will analyse data on an intention to treat basis. P-values below 5 % will be considered statistically significant. Normal distribution will be checked. Means (standard deviations) or medians (ranges or interquartile ranges) will be calculated and unpaired t-tests or Mann Whitney U tests will be used as appropriate to test differences in LOS. Categorical data (success rates) will be analysed using Chi2-tests. Data analysis will be performed using SPSS version 12.
Study population:
Patients with the first episode of a symptomatic pneumothorax or an asymptomatic pneumothorax with a size ≥ 20 % as estimated by Light's formula ( (1-L/H )x100 ) with an age of ≥ 18 and < 85 years.
Intervention: Manual aspiration or conventional chest tube drainage. Primary study endpoint 1. The LOS.
Secondary endpoint:
1.The success rate of each technique:
Conventional chest tube drainage; complete expansion of the lung, counteraction of the air leak and removal of the drain within 72 hours.
Manual aspiration: complete expansion and discharge within 24 hours, success rate at two weeks (continuous expansion) and one year (no recurrence of pneumothorax in the interval period after discharge between 2 weeks and 1 year).
Burden, risks and advantages associated with participation:
The risks of manual aspiration and chest tube drainage techniques are the same. Complications seem to be occur in only 1 % of the aspirations and they consist of haematothorax, retained catheter tips, subcutaneous emphysema and vasovagal reactions. The most important disadvantage is in case of an unsuccessful treatment by manual aspiration with a persisting pneumothorax. Patients in this case have to undergo the conventional tube chest drainage after all. The benefit of the investigational approach is that patients are discharged earlier from the hospital in case of success and its cost effectiveness.
- Conditions
- Pneumothorax
- Being tested
- manual aspiration, conventional drainage
- Keywords
- manual aspiration, conventional, length of stay
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual aspirationProcedure or surgery
air aspiration
conventional drainageProcedure or surgery
drainage, pneumocath
| Study group | Role | What they receive |
|---|---|---|
| manual aspiration | Experimental | manual aspiration Receives: Procedure: manual aspiration |
| conventional drainage | Active comparator | conventional drainage Receives: Procedure: conventional drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of length of stay of each technique
Measured: 1 year
Secondary outcomes (1)
The success rate of each technique
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2010
- Study completionApr 2011
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 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
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan W.K. van den Berg, Isala
- Investigators
- J.W. van den Berg, Dr., Study director, Isala Klinieken department of pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556335
- Sponsor's protocol ID
- NL13097.075.06
- Acronym
- pneumothorax
- Status last verified
- Apr 2013
- First submitted
- 9 Nov 2007
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Noppen M, Alexander P, Driesen P, Slabbynck H, Verstraeten A. Manual aspiration versus chest tube drainage in first episodes of primary spontaneous pneumothorax: a multicenter, prospective, randomized pilot study. Am J Respir Crit Care Med. 2002 May 1;165(9):1240-4. doi: 10.1164/rccm.200111-078OC.
PubMed 11991872Parlak M, Uil SM, van den Berg JW. A prospective, randomised trial of pneumothorax therapy: manual aspiration versus conventional chest tube drainage. Respir Med. 2012 Nov;106(11):1600-5. doi: 10.1016/j.rmed.2012.08.005. Epub 2012 Aug 24.
PubMed 22925840
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised Trial in Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
- ClinicalTrials.gov ID
- NCT00556335
- Acronym / sponsor ID
- pneumothorax / NL13097.075.06
- Conditions
- Pneumothorax
- Keywords
- manual aspiration, conventional, length of stay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 12 Nov 2007 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy of manual aspiration in comparison to conventional chest tube drainage in pneumothorax therapy:
- whether manual aspiration will shorten hospital admission.
- whether the lung will expand by means of clinical and radiological findings.
Detailed description
No consensus has been defined concerning the exact treatment of a first episode of SP. Literature suggests similar immediate and long-term efficacy of manual aspiration and chest tube drainage. Morbidity of manual aspiration is low and the procedure is well tolerated. Manual aspiration is safe with a complication rate of only 1 % and can be performed in the outpatient clinic in the majority of patients reducing costs. Our aim is to re - evaluate these findings with a mono-centre study with 114 patients, set-up for the first time in the Netherlands with an expectancy to confirm the former findings.
Aim of the study:
To evaluate the efficacy of manual aspiration in comparison to conventional chest tube drainage in pneumothorax therapy:
- whether manual aspiration will shorten hospital admission.
- whether the lung will expand by means of clinical and radiological findings.
Study design: prospective single-centre, open randomised trial.
Randomisation:
With a computer minimization program for manual aspiration or usual care with special attendance to the cause of pneumothorax (spontaneous or traumatic), the presence of smoking and gender.
Statistical analysis:
Our primary aim is to demonstrate a higher efficacy for manual aspiration in terms of a shorter admission duration (LOS) in favor of manual aspiration with similar therapy success rates. We will analyse data on an intention to treat basis. P-values below 5 % will be considered statistically significant. Normal distribution will be checked. Means (standard deviations) or medians (ranges or interquartile ranges) will be calculated and unpaired t-tests or Mann Whitney U tests will be used as appropriate to test differences in LOS. Categorical data (success rates) will be analysed using Chi2-tests. Data analysis will be performed using SPSS version 12.
Study population:
Patients with the first episode of a symptomatic pneumothorax or an asymptomatic pneumothorax with a size ≥ 20 % as estimated by Light's formula ( (1-L/H )x100 ) with an age of ≥ 18 and < 85 years.
Intervention: Manual aspiration or conventional chest tube drainage. Primary study endpoint 1. The LOS.
Secondary endpoint:
1.The success rate of each technique:
Conventional chest tube drainage; complete expansion of the lung, counteraction of the air leak and removal of the drain within 72 hours.
Manual aspiration: complete expansion and discharge within 24 hours, success rate at two weeks (continuous expansion) and one year (no recurrence of pneumothorax in the interval period after discharge between 2 weeks and 1 year).
Burden, risks and advantages associated with participation:
The risks of manual aspiration and chest tube drainage techniques are the same. Complications seem to be occur in only 1 % of the aspirations and they consist of haematothorax, retained catheter tips, subcutaneous emphysema and vasovagal reactions. The most important disadvantage is in case of an unsuccessful treatment by manual aspiration with a persisting pneumothorax. Patients in this case have to undergo the conventional tube chest drainage after all. The benefit of the investigational approach is that patients are discharged earlier from the hospital in case of success and its cost effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual aspiration | Experimental | Procedure: manual aspirationmanual aspiration |
| conventional drainage | Active comparator | Procedure: conventional drainageconventional drainage |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a first episode of a symptomatic pneumothorax admitted to the ER of the hospital (spontaneous or traumatic) or
- patients with an asymptomatic pneumothorax with a size of ≥ 20 % as estimated by Light's formula
- age ≥ 18 and < 85 years
- smoking is tolerated
Key exclusion criteria (10 listed)
- recurrent pneumothorax
- lung fibrosis
- patients with (lung) cancer
- pregnant women
- comorbidity limiting decision making (psychiatric disease, alcohol or drug abuse)
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 |
|---|---|---|
| manual aspirationair aspiration | Procedure or surgery | manual aspiration |
| conventional drainagedrainage, pneumocath | Procedure or surgery | conventional drainage |
Primary outcome
The duration of length of stay of each technique
Time frame: 1 year
1 secondary outcome
The success rate of each technique
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- Background: PubMed 11991872Noppen M, Alexander P, Driesen P, Slabbynck H, Verstraeten A. Manual aspiration versus chest tube drainage in first episodes of primary spontaneous pneumothorax: a multicenter, prospective, randomized pilot study. Am J Respir Crit Care Med. 2002 May 1;165(9):1240-4. doi: 10.1164/rccm.200111-078OC.
- Derived from this study: PubMed 22925840Parlak M, Uil SM, van den Berg JW. A prospective, randomised trial of pneumothorax therapy: manual aspiration versus conventional chest tube drainage. Respir Med. 2012 Nov;106(11):1600-5. doi: 10.1016/j.rmed.2012.08.005. Epub 2012 Aug 24.
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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.
J.W. van den Berg, Dr. study director
Isala Klinieken department of pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manual aspiration and conventional drainage in people with Pneumothorax, run by Isala at 1 site in Netherlands.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 8 Apr 2013. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The duration of length of stay of each technique (time frame: 1 year). 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 NCT00556335, 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 8 Apr 2013.