NCT03546764

Brief Summary

After sustaining severe trauma to the chest, patients will often bleed into the chest cavity (pleural space) which is called hemothorax or they may also experience air leakage within the chest cavity in combination with the bleeding (hemopneumothorax). These conditions are treated with the insertion of a tube into the chest called a chest tube (CT). Insertion of the CT is very painful for the patient due to the size or diameter of the tube. Alternative to CT is a small percutaneous catheter (PC), pigtail or non-pigtail. At Banner-University of Arizona Tucson Campus (B-UATC) investigator prefers inserting a small pigtail catheter for the management of hemothorax or hemopnuemothorax. The primary purpose of our study is to see if the use of the PC is just as effective as CT in terms of removing leaked blood and/or air from the chest cavity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2.7 years

First QC Date

March 13, 2018

Last Update Submit

April 28, 2021

Conditions

The Efficacy of Percutaneous Catheter vs. Open Chest TubeTraumatic Hemothorax

Keywords

Percutatneous catheterchest tubetraumahemothorax

Outcome Measures

Primary Outcomes (1)

  • Failure rate

    Failure rate is defined as any second intervention to treat retained hemothorax

    30 days

Secondary Outcomes (2)

  • Insertion-related complication

    30 days

  • Hospital course outcome

    30 days

Study Arms (2)

Percutaneous Catheter

EXPERIMENTAL

14-French Percutaneous catheter (pigtail or non-pigtail) placed at bedside using Seldinger technique

Device: Percutaneous catheter

Chest tube

ACTIVE COMPARATOR

Placement of 28-36F chest tube placed at bedside by an open cut-down technique (traditional)

Device: Percutaneous catheter

Interventions

Percutaneous catheterDEVICE

tube inserted to drain hemothorax

Also known as: tube insertion
Chest tubePercutaneous Catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • Traumatic HTX/HPTX requiring chest tube insertion

You may not qualify if:

  • Emergent indication, hemodynamic instability
  • Patient refuses to participate
  • Prisoner
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Ariznoa Medican Center, Main campus

Tucson, Arizona, 85724, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Nebrask

Omaha, Nebraska, 68198, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (7)

  • Bauman ZM, Kulvatunyou N. 14-French Pigtail Catheters for Traumatic Hemothorax/Hemopneumothorax: Size Does Not Matter: Reply. World J Surg. 2018 Aug;42(8):2687-2688. doi: 10.1007/s00268-018-4508-y. No abstract available.

    PMID: 29423739RESULT

  • Bauman ZM, Kulvatunyou N, Joseph B, Jain A, Friese RS, Gries L, O'Keeffe T, Tang AL, Vercruysse G, Rhee P. A Prospective Study of 7-Year Experience Using Percutaneous 14-French Pigtail Catheters for Traumatic Hemothorax/Hemopneumothorax at a Level-1 Trauma Center: Size Still Does Not Matter. World J Surg. 2018 Jan;42(1):107-113. doi: 10.1007/s00268-017-4168-3.

    PMID: 28795207RESULT

  • 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.

    PMID: 24375295RESULT

  • Kulvatunyou N, Joseph B, Friese RS, Green D, Gries L, O'Keeffe T, Tang AL, Wynne JL, Rhee P. 14 French pigtail catheters placed by surgeons to drain blood on trauma patients: is 14-Fr too small? J Trauma Acute Care Surg. 2012 Dec;73(6):1423-7. doi: 10.1097/TA.0b013e318271c1c7.

    PMID: 23188235RESULT

  • Kulvatunyou N, Vijayasekaran A, Hansen A, Wynne JL, O'Keeffe T, Friese RS, Joseph B, Tang A, Rhee P. Two-year experience of using pigtail catheters to treat traumatic pneumothorax: a changing trend. J Trauma. 2011 Nov;71(5):1104-7; discussion 1107. doi: 10.1097/TA.0b013e31822dd130.

    PMID: 22071915RESULT

  • Hylands M, Gomez D, Beckett A. Letter to the editor: The small (14 Fr) percutaneous catheter (P-CAT) versus large (28-32 Fr) open chest tube for traumatic hemothorax: A multicenter randomized clinical trial. J Trauma Acute Care Surg. 2022 Sep 1;93(3):e125. doi: 10.1097/TA.0000000000003647. Epub 2022 May 25. No abstract available.

    PMID: 35610739DERIVED

  • Kulvatunyou N, Bauman ZM, Zein Edine SB, de Moya M, Krause C, Mukherjee K, Gries L, Tang AL, Joseph B, Rhee P. The small (14 Fr) percutaneous catheter (P-CAT) versus large (28-32 Fr) open chest tube for traumatic hemothorax: A multicenter randomized clinical trial. J Trauma Acute Care Surg. 2021 Nov 1;91(5):809-813. doi: 10.1097/TA.0000000000003180.

    PMID: 33843831DERIVED

MeSH Terms

Conditions

Wounds and InjuriesHemothorax

Interventions

Catheter AblationMiddle Ear Ventilation

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeOstomyOtologic Surgical ProceduresOtorhinolaryngologic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient does not know the details of the treatment assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arms - Percutaneous catheter arm vs Chest tube arm
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2018

First Posted

June 6, 2018

Study Start

March 1, 2018

Primary Completion

November 1, 2020

Study Completion

February 1, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(4)