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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jan W.K. van den Berg, Isala Klinieken
ClinicalTrials.gov Identifier:
NCT00556335
First received: November 9, 2007
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Pneumothorax
 Procedure: manual aspiration
Procedure: conventional drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomised Trial in Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isala Klinieken:

Primary Outcome Measures:
  • The duration of length of stay of each technique [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The success rate of each technique [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: April 2007
Study Completion Date: April 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: manual aspiration
manual aspiration
 Procedure: manual aspiration
air aspiration
Active Comparator: conventional drainage
conventional drainage
 Procedure: conventional drainage
drainage, pneumocath

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556335

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jan W.K. van den Berg, Dr., Isala Klinieken
ClinicalTrials.gov Identifier: NCT00556335     History of Changes
Other Study ID Numbers: NL13097.075.06
Study First Received: November 9, 2007
Last Updated: April 5, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:
manual aspiration
conventional
length of stay

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013