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

April 28, 2021 updated by: University of Arizona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Ariznoa Medican Center, Main campus
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebrask
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous Catheter
14-French Percutaneous catheter (pigtail or non-pigtail) placed at bedside using Seldinger technique
Device: Percutaneous catheter
tube inserted to drain hemothorax
Other Names:
  • tube insertion
Active Comparator: Chest tube
Placement of 28-36F chest tube placed at bedside by an open cut-down technique (traditional)
Device: Percutaneous catheter
tube inserted to drain hemothorax
Other Names:
  • tube insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure rate
Time Frame: 30 days
Failure rate is defined as any second intervention to treat retained hemothorax
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insertion-related complication
Time Frame: 30 days
any insertion-related complication, minor or major
30 days
Hospital course outcome
Time Frame: 30 days
ICU length of stay, hospital length of stay
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Cook Group Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

March 13, 2018

First Submitted That Met QC Criteria

June 1, 2018

First Posted (Actual)

June 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1506936985A001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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