Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

Traumatic Pneumothorax Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01537289
• Other study ID #: 10-0405-03
• Status: Unknown status
• Phase: Phase 3
• First received: February 9, 2012
• Last updated: February 22, 2012
• Start date: July 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2012
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary outcome: - Tube site pain

• Pain medication requirement

Secondary outcome: failure rate insertion-related complication

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 38
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax
• Traumatic Pneumothorax

Intervention

Device:
• Pigtail catheter insertion (Cook)
insertion of pigtail catheter to decompress pneumothorax
• chest tube (28-French)
inserting chest tube to decompress pneumothorax

Locations

Country	Name	City	State
United States	University of Ariznoa Medican Center, Main campus	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tube-site pain, pain medication requirement		day 0, 1, 2
Secondary	failure rate		patients will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Insertion-related complication		day 0