Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage (pneumothorax)

April 5, 2013 updated by: Jan W.K. van den Berg, Isala

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:

  1. whether manual aspiration will shorten hospital admission.
  2. whether the lung will expand by means of clinical and radiological findings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zwolle, Netherlands, 8011 JW
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • recurrent pneumothorax
  • lung fibrosis
  • patients with (lung) cancer
  • pregnant women
  • comorbidity limiting decision making (psychiatric disease, alcohol or drug abuse)
  • prior randomisation
  • Marfan syndrome
  • COPD patients
  • tension pneumothorax
  • multitrauma patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: manual aspiration
Procedure: manual aspiration
air aspiration
ACTIVE_COMPARATOR: conventional drainage
Procedure: conventional drainage
drainage, pneumocath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The duration of length of stay of each technique
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The success rate of each technique
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isala

Investigators

  • Study Director: J.W. van den Berg, Dr., Isala Klinieken department of pulmonology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

November 9, 2007

First Submitted That Met QC Criteria

November 9, 2007

First Posted (ESTIMATE)

November 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL13097.075.06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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