Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

February 22, 2012 updated by: Narong Kulvatunyou, University of Arizona

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary outcome: - Tube site pain

  • Pain medication requirement

Secondary outcome: failure rate insertion-related complication

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pigtail catheter
Device: Pigtail catheter insertion (Cook)
insertion of pigtail catheter to decompress pneumothorax
Other Names:
  • 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 Names:
  • 28-French chest tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Tube-site pain, pain medication requirement
Time Frame: day 0, 1, 2
day 0, 1, 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: narong kulvatunyou, MD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

February 23, 2012

Last Update Submitted That Met QC Criteria

February 22, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0405-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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