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Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

This study is currently recruiting participants.
Verified February 2012 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Narong Kulvatunyou, University of Arizona
ClinicalTrials.gov Identifier:
NCT01537289
First received: February 9, 2012
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Traumatic Pneumothorax
 Device: Pigtail catheter insertion (Cook)
Device: chest tube (28-French)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Change in Tube-site pain, pain medication requirement [ Time Frame: day 0, 1, 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • failure rate [ Time Frame: patients will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
  • Insertion-related complication [ Time Frame: day 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: July 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Primary outcome: - Tube site pain

  • Pain medication requirement

Secondary outcome: failure rate insertion-related complication

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537289

Locations
United States, Arizona
University of Ariznoa Medican Center, Main campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Narong Kulvatunyou, MD     520-626-6302     nkulvatunyou@surgery.arizona.edu    
Contact: Coy Collins, RN     520-626-2876     ccollins@surgery.arizona.edu    
Principal Investigator: Narong Kulvatunyou, MD            
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: narong kulvatunyou, MD University of Arizona
  More Information

No publications provided

Responsible Party: Narong Kulvatunyou, Assistant Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT01537289     History of Changes
Other Study ID Numbers: 10-0405-03
Study First Received: February 9, 2012
Last Updated: February 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Trauma
Pneumothorax

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013