Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage - Full Text View

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

This study is currently recruiting participants.
Verified by Isala Klinieken, November 2007

Sponsored by:	Isala Klinieken
Information provided by:	Isala Klinieken
ClinicalTrials.gov Identifier:	NCT00556335

Purpose

The purpose of this study is to evaluate the efficacy of manual aspiration in comparison to conventional chest tube drainage in pneumothorax therapy:

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

Condition	Intervention
Pneumothorax	Procedure: manual aspiration Procedure: conventional drainage

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Prospective, Randomised Trial in Pneumothorax Therapy: Manual Aspiration Versus Conventional Chest Tube Drainage

Further study details as provided by Isala Klinieken:

Primary Outcome Measures:

The duration of length of stay of each technique [ Time Frame: 1 year ]

Secondary Outcome Measures:

The success rate of each technique [ Time Frame: 1 year ]

Estimated Enrollment:	114
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2009

Arms	Assigned Interventions
A: Experimental manual aspiration	Procedure: manual aspiration air aspiration
B: Active Comparator 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
multi-trauma patients

Contacts and Locations

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

Contacts


Contact: J.W. van den Berg, PhD	+31 38 4242000 ext 4474	j.w.k.van.den.berg@isala.nl

Locations


Netherlands
	Isala Klinieken	Recruiting
	Zwolle, Netherlands, 8011 JW
	Contact: J.W. van den Berg, Dr. 038-4242000 ext 4474
	Principal Investigator: L.N. Boom

Sponsors and Collaborators

Isala Klinieken

Investigators


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

More Information

Publications:

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.

Study ID Numbers:	NL13097.075.06
First Received:	November 9, 2007
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00556335
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:

manual aspiration

conventional

length of stay

Study placed in the following topic categories:

Respiratory Tract Diseases

Pleural Diseases

Pneumothorax

ClinicalTrials.gov processed this record on September 22, 2008