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Comparing 14 F Pigtail Catheter to Traditional 28-32F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax

Primary Purpose

Traumatic Hemothorax

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pigtail catheter
Sponsored by
Narong Kulvatunyou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Hemothorax focused on measuring pigtail catheter, small-bore catheter, trauma, hemothorax

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Emergent indication, hemodynamic instability
  2. Patient refuses to participate
  3. Prisoner
  4. Intubation and/or on the ventilator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pigtail catheter (case)

    Chest tube

    Arm Description

    Inserting 14 French pigtail catheter

    inserting 32-36 French chest tube

    Outcomes

    Primary Outcome Measures

    Number of participants with failure of initial intervention
    Requiring a second intervention i.e., second tube, VATS, etc

    Secondary Outcome Measures

    initial drainage (blood) output at the time of tube insertion
    the amount of blood that comes out when tube is placed

    Full Information

    First Posted
    August 3, 2015
    Last Updated
    September 16, 2015
    Sponsor
    Narong Kulvatunyou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02553434
    Brief Title
    Comparing 14 F Pigtail Catheter to Traditional 28-32F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax
    Official Title
    Prospective and Randomized Study Comparing 14 F Pigtail Catheter to Traditional 32-36F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Narong Kulvatunyou

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    The standard treatment for traumatic hemothorax (HTX) and hemopneumothorax (HPTX) has been an insertion of a large-bore chest tube (CT) (French 28-32). The procedure is associated with significant patient's pain and discomfort. Investigator's institution has taken a lead role to replace chest tube insertion with pigtail catheter (PC) (14F) insertion. The investigators have previously published that, not only PC works just as well as the traditional CT for both pneumothorax 1) and hemothorax( 2), but it is also associated with a significant less insertion pain and tube site pain (3). In that hemothorax study, investigator reported 36 patients who received PC for HTX (2) with the same success as 32-36F chest tube in term of initial output and success rate; success rate was defined as no further intervention was needed. Since the completion of that study (December 2011), investigator's division has inserted probably 100 PC for hemothorax and hemopneumohthorax Therefore, the investigators now believe that it is time for the investigator to demonstrate the efficacy of the PC for hemothorax with a prospective and randomized study as the investigator had done previously for traumatic pneumothorax (3). The investigators hypothesize that pigtail catheter will be just as effective as the chest tube in patients with traumatic HTX and HPTX. The investigators' study aim is to demonstrate the efficacy of the pigtail catheter in a prospective and randomized fashion as we have done previously in pneumothorax. The investigators' primary end point is the success/failure rate. Failure is defined as a second intervention is required i.e., second tube, video-assisted thoracoscopy (VATS), etc. The investigators' secondary end points are the amount of initial tube drainage, 24-hour, 48-hour, 72-hour; and complications, hospital length of stay, and chest tube or pigtail insertion experience as expressed by the patient.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Hemothorax
    Keywords
    pigtail catheter, small-bore catheter, trauma, hemothorax

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pigtail catheter (case)
    Arm Type
    Experimental
    Arm Description
    Inserting 14 French pigtail catheter
    Arm Title
    Chest tube
    Arm Type
    No Intervention
    Arm Description
    inserting 32-36 French chest tube
    Intervention Type
    Device
    Intervention Name(s)
    Pigtail catheter
    Other Intervention Name(s)
    small-bore catheter
    Intervention Description
    Insertion of pigtail catheter
    Primary Outcome Measure Information:
    Title
    Number of participants with failure of initial intervention
    Description
    Requiring a second intervention i.e., second tube, VATS, etc
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    initial drainage (blood) output at the time of tube insertion
    Description
    the amount of blood that comes out when tube is placed
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: Emergent indication, hemodynamic instability Patient refuses to participate Prisoner Intubation and/or on the ventilator
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Narong Kulvatunyou, MD
    Phone
    520-626-6608
    Email
    nkulvatunyou@surgery.arizona.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Narong Kulvatunyou, MD
    Organizational Affiliation
    University of Arizona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24375295
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    23188235
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    33415448
    Citation
    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.
    Results Reference
    derived

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    Comparing 14 F Pigtail Catheter to Traditional 28-32F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax

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