Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Arizona.
Recruitment status was  Recruiting
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
  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:


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
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: 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 by University of Arizona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 23, 2014