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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556335
Recruitment Status : Completed
First Posted : November 12, 2007
Last Update Posted : April 8, 2013
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala

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.

Condition or disease Intervention/treatment Phase
Pneumothorax Procedure: manual aspiration Procedure: conventional drainage Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised Trial in Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
Study Start Date : April 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Experimental: manual aspiration
manual aspiration
Procedure: manual aspiration
air aspiration

Active Comparator: conventional drainage
conventional drainage
Procedure: conventional drainage
drainage, pneumocath

Primary Outcome Measures :
  1. The duration of length of stay of each technique [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. The success rate of each technique [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556335

Isala Klinieken
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
Study Director: J.W. van den Berg, Dr. Isala Klinieken department of pulmonology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jan W.K. van den Berg, Dr., Isala Identifier: NCT00556335     History of Changes
Other Study ID Numbers: NL13097.075.06
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Jan W.K. van den Berg, Isala:
manual aspiration
length of stay

Additional relevant MeSH terms:
Pleural Diseases
Respiratory Tract Diseases