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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Percutaneous catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 Traumatic HTX/HPTX requiring chest tube insertion Exclusion Criteria: Emergent indication, hemodynamic instability Patient refuses to participate Prisoner Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two arms - Percutaneous catheter arm vs Chest tube arm
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, Percutatneous catheter, chest tube, hemothorax