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
About this trial
This is an interventional treatment trial for Traumatic Hemothorax focused on measuring pigtail catheter, small-bore catheter, trauma, hemothorax
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
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
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
Learn more about this trial
Comparing 14 F Pigtail Catheter to Traditional 28-32F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax
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