Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
pneumothorax
A Prospective, Randomised Trial in Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 9, 2007
CompletedFirst Posted
Study publicly available on registry
November 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedApril 8, 2013
April 1, 2013
3 years
November 9, 2007
April 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The duration of length of stay of each technique
1 year
Secondary Outcomes (1)
The success rate of each technique
1 year
Study Arms (2)
manual aspiration
EXPERIMENTALmanual aspiration
conventional drainage
ACTIVE COMPARATORconventional drainage
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Isalalead
Study Sites (1)
Isala Klinieken
Zwolle, 8011 JW, Netherlands
Related Publications (2)
Noppen M, Alexander P, Driesen P, Slabbynck H, Verstraeten A. Manual aspiration versus chest tube drainage in first episodes of primary spontaneous pneumothorax: a multicenter, prospective, randomized pilot study. Am J Respir Crit Care Med. 2002 May 1;165(9):1240-4. doi: 10.1164/rccm.200111-078OC.
PMID: 11991872BACKGROUNDParlak M, Uil SM, van den Berg JW. A prospective, randomised trial of pneumothorax therapy: manual aspiration versus conventional chest tube drainage. Respir Med. 2012 Nov;106(11):1600-5. doi: 10.1016/j.rmed.2012.08.005. Epub 2012 Aug 24.
PMID: 22925840DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
J.W. van den Berg, Dr.
Isala Klinieken department of pulmonology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 9, 2007
First Posted
November 12, 2007
Study Start
April 1, 2007
Primary Completion
April 1, 2010
Study Completion
April 1, 2011
Last Updated
April 8, 2013
Record last verified: 2013-04