Pigtail Catheter Versus Chest Tube in the Management of T... | NCT01537289

Studies
Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

NCT01537289

Sponsor

University of Arizona

Status

Unknown status

Last Update Posted

Feb 23, 2012Estimated

Enrollment

38Estimated

Phase

Phase 3

Conditions

Traumatic Pneumothorax

Interventions

Pigtail catheter insertion (Cook)
chest tube (28-French)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Jun 2012Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Feb 9, 2012

First Submission Date that Met QC Criteria

Feb 22, 2012

First Posted Date

Feb 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2012

Last Update Posted Date

Feb 23, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pigtail catheter	Experimental		Device: Pigtail catheter insertion (Cook)
Traditional chest tube	Active Comparator	28-French chest tube	Device: chest tube (28-French)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pigtail catheter insertion (Cook)	Device	insertion of pigtail catheter to decompress pneumothorax	Pigtail catheter

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
narong kulvatunyou, MD	University of Arizona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ariznoa Medican Center, Main campus	Recruiting	Tucson	Arizona	85724	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24375295	Derived	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.

Type	Date	Date Unknown
Release	Sep 16, 2015
Reset	Oct 16, 2015

ID	Term
D014947	Wounds and Injuries
D011030	Pneumothorax

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases

ID	Term
D013523	Surgical Equipment
D004864	Equipment and Supplies