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Multi-center:The Small (14F) Percutaneous Catheter vs. Large (28-40F) Open Chest Tube for Traumatic Hemothorax (P-CAT) (P-CAT)

Primary Purpose

The Efficacy of Percutaneous Catheter vs. Open Chest Tube, Traumatic Hemothorax

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous catheter
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Efficacy of Percutaneous Catheter vs. Open Chest Tube focused on measuring Percutatneous catheter, chest tube, trauma, hemothorax

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age > 18
  2. Traumatic HTX/HPTX requiring chest tube insertion

Exclusion Criteria:

  1. Emergent indication, hemodynamic instability
  2. Patient refuses to participate
  3. Prisoner
  4. Pregnancy

Sites / Locations

  • University of Ariznoa Medican Center, Main campus
  • Emory University
  • University of Nebrask
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Percutaneous Catheter

Chest tube

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Insertion-related complication
any insertion-related complication, minor or major
Hospital course outcome
ICU length of stay, hospital length of stay

Full Information

First Posted
March 13, 2018
Last Updated
April 28, 2021
Sponsor
University of Arizona
Collaborators
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03546764
Brief Title
Multi-center:The Small (14F) Percutaneous Catheter vs. Large (28-40F) Open Chest Tube for Traumatic Hemothorax (P-CAT)
Acronym
P-CAT
Official Title
The Small (14F) Percutaneous Catheter vs. Large (28-40F) Open Chest Tube for Traumatic Hemothorax (P-CAT): A Multi-center Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Cook Group Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
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). 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.
Detailed Description
The standard treatment for traumatic hemothorax (HTX) and hemopneumothorax (HPTX) has been an insertion of a large-bore chest tube (CT) (French 28-40). The procedure is associated with significant patient's pain and discomfort. Our institution has taken a lead role to replace chest tube insertion with percutaneous (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 32F 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), our division has inserted probably 100 PC for hemothorax and hemopneumohthorax Therefore, investigator now believes that it is time for us to demonstrate the efficacy of the PC for hemothorax with a prospective and randomized study as investigators have done previously for traumatic pneumothorax (3). The investigator hypothesizes that PC will be just as effective as CT in patients with traumatic HTX and HPTX. Our study aim is to demonstrate the efficacy of the PC in a prospective and randomized fashion as we have done previously in pneumothorax. Our primary end point is the success/failure rate. Failure is defined as patient require a second intervention i.e., second tube, video-assisted thoracoscopy (VATS), etc. Our secondary end points are the amount of initial tube drainage (1-hour), 24-hour, 48-hour, 72-hour; tube insertion-related complications, hospital length of stay, and patient's experience during CT/PC insertion (if patient can provide the information). Significance of the study: Currently, most trauma surgeons prefer CT over PC for the management of traumatic HTX. The study will provide a level 1 scientific evidence that PC works as well as CT for traumatic HTX/HPTX, and we have already shown that PC is less painful than CT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Efficacy of Percutaneous Catheter vs. Open Chest Tube, Traumatic Hemothorax
Keywords
Percutatneous catheter, chest tube, trauma, hemothorax

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arms - Percutaneous catheter arm vs Chest tube arm
Masking
Participant
Masking Description
Patient does not know the details of the treatment assignment
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Catheter
Arm Type
Experimental
Arm Description
14-French Percutaneous catheter (pigtail or non-pigtail) placed at bedside using Seldinger technique
Arm Title
Chest tube
Arm Type
Active Comparator
Arm Description
Placement of 28-36F chest tube placed at bedside by an open cut-down technique (traditional)
Intervention Type
Device
Intervention Name(s)
Percutaneous catheter
Other Intervention Name(s)
tube insertion
Intervention Description
tube inserted to drain hemothorax
Primary Outcome Measure Information:
Title
Failure rate
Description
Failure rate is defined as any second intervention to treat retained hemothorax
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Insertion-related complication
Description
any insertion-related complication, minor or major
Time Frame
30 days
Title
Hospital course outcome
Description
ICU length of stay, hospital length of stay
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age > 18 Traumatic HTX/HPTX requiring chest tube insertion Exclusion Criteria: Emergent indication, hemodynamic instability Patient refuses to participate Prisoner Pregnancy
Facility Information:
Facility Name
University of Ariznoa Medican Center, Main campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Nebrask
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29423739
Citation
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.
Results Reference
result
PubMed Identifier
28795207
Citation
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.
Results Reference
result
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
22071915
Citation
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.
Results Reference
result
PubMed Identifier
35610739
Citation
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.
Results Reference
derived
PubMed Identifier
33843831
Citation
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.
Results Reference
derived

Learn more about this trial

Multi-center:The Small (14F) Percutaneous Catheter vs. Large (28-40F) Open Chest Tube for Traumatic Hemothorax (P-CAT)

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