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Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

Primary Purpose

Traumatic Pneumothorax

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pigtail catheter insertion (Cook)
chest tube (28-French)
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Pneumothorax focused on measuring Trauma, Pneumothorax

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Ariznoa Medican Center, Main campusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pigtail catheter

Traditional chest tube

Arm Description

28-French chest tube

Outcomes

Primary Outcome Measures

Change in Tube-site pain, pain medication requirement

Secondary Outcome Measures

failure rate
Insertion-related complication

Full Information

First Posted
February 9, 2012
Last Updated
February 22, 2012
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT01537289
Brief Title
Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Primary outcome: - Tube site pain Pain medication requirement Secondary outcome: failure rate insertion-related complication

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Pneumothorax
Keywords
Trauma, Pneumothorax

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pigtail catheter
Arm Type
Experimental
Arm Title
Traditional chest tube
Arm Type
Active Comparator
Arm Description
28-French chest tube
Intervention Type
Device
Intervention Name(s)
Pigtail catheter insertion (Cook)
Other Intervention Name(s)
Cook Critical Care, Cook Incorporated, Bloomington, IN)
Intervention Description
insertion of pigtail catheter to decompress pneumothorax
Intervention Type
Device
Intervention Name(s)
chest tube (28-French)
Other Intervention Name(s)
28-French chest tube
Intervention Description
inserting chest tube to decompress pneumothorax
Primary Outcome Measure Information:
Title
Change in Tube-site pain, pain medication requirement
Time Frame
day 0, 1, 2
Secondary Outcome Measure Information:
Title
failure rate
Time Frame
patients will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
Insertion-related complication
Time Frame
day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
narong kulvatunyou, MD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ariznoa Medican Center, Main campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Narong Kulvatunyou, MD
Phone
520-626-6302
Email
nkulvatunyou@surgery.arizona.edu
First Name & Middle Initial & Last Name & Degree
Coy Collins, RN
Phone
520-626-2876
Email
ccollins@surgery.arizona.edu
First Name & Middle Initial & Last Name & Degree
Narong Kulvatunyou, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
24375295
Citation
Kulvatunyou N, Erickson L, Vijayasekaran A, Gries L, Joseph B, Friese RF, O'Keeffe T, Tang AL, Wynne JL, Rhee P. Randomized clinical trial of pigtail catheter versus chest tube in injured patients with uncomplicated traumatic pneumothorax. Br J Surg. 2014 Jan;101(2):17-22. doi: 10.1002/bjs.9377.
Results Reference
derived

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Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

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