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Pigtail Catheter Versus Chest Tube in the Management of Traumatic 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: NCT01537289
Recruitment Status : Unknown
Verified February 2012 by Narong Kulvatunyou, University of Arizona.
Recruitment status was:  Recruiting
First Posted : February 23, 2012
Last Update Posted : February 23, 2012
Information provided by (Responsible Party):
Narong Kulvatunyou, University of Arizona

Brief Summary:

A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.

There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT.

Condition or disease Intervention/treatment Phase
Traumatic Pneumothorax Device: Pigtail catheter insertion (Cook) Device: chest tube (28-French) Phase 3

Detailed Description:

Primary outcome: - Tube site pain

  • Pain medication requirement

Secondary outcome: failure rate insertion-related complication

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study of 14-French (14F) Pigtail Catheters Versus 28F Chest Tubes in Patients With Traumatic Pneumothorax: Impact on Tube-Site Pain and Failure Rate
Study Start Date : July 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Arm Intervention/treatment
Experimental: Pigtail catheter Device: Pigtail catheter insertion (Cook)
insertion of pigtail catheter to decompress pneumothorax
Other Name: Cook Critical Care, Cook Incorporated, Bloomington, IN)

Active Comparator: Traditional chest tube
28-French chest tube
Device: chest tube (28-French)
inserting chest tube to decompress pneumothorax
Other Name: 28-French chest tube

Primary Outcome Measures :
  1. Change in Tube-site pain, pain medication requirement [ Time Frame: day 0, 1, 2 ]

Secondary Outcome Measures :
  1. failure rate [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 2 weeks ]
  2. Insertion-related complication [ Time Frame: day 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 years old and above
  • Suffer traumatic pneumothorax that requires chest tube insertion

Exclusion Criteria:

  • Emergency chest tube insertion
  • patient refuses
  • patient is unable to provide or rate pain assessment
  • prisoner
  • pregnancy
  • patient with GCS less than 13

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): NCT01537289

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United States, Arizona
University of Ariznoa Medican Center, Main campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Narong Kulvatunyou, MD    520-626-6302   
Contact: Coy Collins, RN    520-626-2876   
Principal Investigator: Narong Kulvatunyou, MD         
Sponsors and Collaborators
University of Arizona
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Principal Investigator: narong kulvatunyou, MD University of Arizona
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Narong Kulvatunyou, Assistant Professor, University of Arizona Identifier: NCT01537289    
Other Study ID Numbers: 10-0405-03
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 2012
Keywords provided by Narong Kulvatunyou, University of Arizona:
Additional relevant MeSH terms:
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Pleural Diseases
Respiratory Tract Diseases