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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 10, 2014