NCT02553434

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). The treatment for these conditions include the insertion of a tube into the chest called a chest tube). Insertion of the chest tube is commonly very painful for the patient due to the size or diameter of the tube. Alternatively, procedure it is standard practice in the acute care setting at Banner-University of Arizona Tucson Campus (B-UATC) to insert a pigtail catheter, which has a smaller diameter, into the chest wall to treat the hemothorax or hemopnuemothorax. The primary purpose of this study is to see if the use of the pigtail catheter is just as effective as chest tube insertion in terms of removing leaked blood and/or air from the chest cavity. An additional objective of this study is to evaluate which procedure is less painful for the patient.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_3

Status
unknown

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

First Submitted

Initial submission to the registry

August 3, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

August 3, 2015

Last Update Submit

September 16, 2015

Conditions

Traumatic Hemothorax

Keywords

pigtail cathetersmall-bore cathetertraumahemothorax

Outcome Measures

Primary Outcomes (1)

  • Number of participants with failure of initial intervention

    Requiring a second intervention i.e., second tube, VATS, etc

    1 year

Secondary Outcomes (1)

  • initial drainage (blood) output at the time of tube insertion

    1 year

Study Arms (2)

Pigtail catheter (case)

EXPERIMENTAL

Inserting 14 French pigtail catheter

Device: Pigtail catheter

Chest tube

NO INTERVENTION

inserting 32-36 French chest tube

Interventions

Pigtail catheterDEVICE

Insertion of pigtail catheter

Also known as: small-bore catheter
Pigtail catheter (case)

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Traumatic hemothorax/HPTX requiring chest tube insertion (but not as an emergency)
  • Patient is conscious, GCS 14-15, and able to report tube insertion experience
  • English speaking subjects (we plan to have the consent translated in Spanish following approval)

You may not qualify if:

  • Emergent indication, hemodynamic instability
  • Patient refuses to participate
  • Prisoner
  • Intubation and/or on the ventilator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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

  • Bauman ZM, Kulvatunyou N, Joseph B, Gries L, O'Keeffe T, Tang AL, Rhee P. Randomized Clinical Trial of 14-French (14F) Pigtail Catheters versus 28-32F Chest Tubes in the Management of Patients with Traumatic Hemothorax and Hemopneumothorax. World J Surg. 2021 Mar;45(3):880-886. doi: 10.1007/s00268-020-05852-0. Epub 2021 Jan 7.

    PMID: 33415448DERIVED

MeSH Terms

Conditions

Wounds and InjuriesHemothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Narong Kulvatunyou, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Narong Kulvatunyou, MD

CONTACT

520-626-6608nkulvatunyou@surgery.arizona.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Surgery

Study Record Dates

First Submitted

August 3, 2015

First Posted

September 17, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

September 17, 2015

Record last verified: 2015-09