Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-05 @ 6:00 PM
Study NCT ID:
NCT00556335
Status:
COMPLETED
Last Update Posted:
2013-04-08
First Post:
2007-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
Sponsor:
Isala
Organization:
Study Overview
Official Title:
A Prospective, Randomised Trial in Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
Status:
COMPLETED
Status Verified Date:
2013-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pneumothorax
Brief 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.
1. whether manual aspiration will shorten hospital admission.
2. 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:
1. whether manual aspiration will shorten hospital admission.
2. 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.
Aim of the study:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: