Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax

NCT ID: NCT01537289

Last Updated: 2012-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Primary outcome: - Tube site pain

* Pain medication requirement

Secondary outcome: failure rate insertion-related complication

Conditions

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Traumatic Pneumothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pigtail catheter

Group Type EXPERIMENTAL

Pigtail catheter insertion (Cook)

Intervention Type DEVICE

insertion of pigtail catheter to decompress pneumothorax

Traditional chest tube

28-French chest tube

Group Type ACTIVE_COMPARATOR

chest tube (28-French)

Intervention Type DEVICE

inserting chest tube to decompress pneumothorax

Interventions

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Pigtail catheter insertion (Cook)

insertion of pigtail catheter to decompress pneumothorax

Intervention Type DEVICE

chest tube (28-French)

inserting chest tube to decompress pneumothorax

Intervention Type DEVICE

Other Intervention Names

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Cook Critical Care, Cook Incorporated, Bloomington, IN) 28-French chest tube

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Narong Kulvatunyou

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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narong kulvatunyou, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Ariznoa Medican Center, Main campus

Tucson, Arizona, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Narong Kulvatunyou, MD

Role: primary

520-626-6302

Coy Collins, RN

Role: backup

520-626-2876

References

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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.

Reference Type DERIVED
PMID: 24375295 (View on PubMed)

Other Identifiers

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10-0405-03

Identifier Type: -

Identifier Source: org_study_id

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