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

Status:	Recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	2/20/2019
Start Date:	March 1, 2018
End Date:	December 31, 2020
Contact:	Narong Kulvatunyou, MD
Email:	nkulvatunyou@surgery.arizona.edu
Phone:	5206266608

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.

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.

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

We found this trial at

sites

University of Ariznoa Medican Center, Main campus

Tucson, Arizona 85724

Principal Investigator: Narong Kulvatunyou, MD

Phone: 520-626-6302

from

Tucson, AZ