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

Traumatic Hemothorax Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03546764
• Other study ID #: 1506936985A001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Percutaneous catheter
tube inserted to drain hemothorax

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Nebrask	Omaha	Nebraska
United States	University of Ariznoa Medican Center, Main campus	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Cook Group Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 Traum — View 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. — View 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 — View 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: 10.109 — View 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: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure rate	Failure rate is defined as any second intervention to treat retained hemothorax	30 days
Secondary	Insertion-related complication	any insertion-related complication, minor or major	30 days
Secondary	Hospital course outcome	ICU length of stay, hospital length of stay	30 days