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

NCT ID: NCT03546764

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-02-01

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). 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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Percutaneous Catheter

14-French Percutaneous catheter (pigtail or non-pigtail) placed at bedside using Seldinger technique

Group Type: EXPERIMENTAL

Percutaneous catheter

Intervention Type: DEVICE

tube inserted to drain hemothorax

Chest tube

Placement of 28-36F chest tube placed at bedside by an open cut-down technique (traditional)

Group Type: ACTIVE_COMPARATOR

Percutaneous catheter

Intervention Type: DEVICE

tube inserted to drain hemothorax

Interventions

Percutaneous catheter

tube inserted to drain hemothorax

Intervention Type: DEVICE

Other Intervention Names

tube insertion

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cook Group Incorporated

INDUSTRY

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Ariznoa Medican Center, Main campus

Tucson, Arizona, United States

Emory University

Atlanta, Georgia, United States

University of Nebrask

Omaha, Nebraska, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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. No abstract available.

Reference Type: RESULT

PMID: 29423739 (View on PubMed)

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 Trauma Center: Size Still Does Not Matter. World J Surg. 2018 Jan;42(1):107-113. doi: 10.1007/s00268-017-4168-3.

Reference Type: RESULT

PMID: 28795207 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24375295 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23188235 (View on PubMed)

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: 10.1097/TA.0b013e31822dd130.

Reference Type: RESULT

PMID: 22071915 (View on PubMed)

Hylands M, Gomez D, Beckett A. Letter to the editor: The small (14 Fr) percutaneous catheter (P-CAT) versus large (28-32 Fr) open chest tube for traumatic hemothorax: A multicenter randomized clinical trial. J Trauma Acute Care Surg. 2022 Sep 1;93(3):e125. doi: 10.1097/TA.0000000000003647. Epub 2022 May 25. No abstract available.

Reference Type: DERIVED

PMID: 35610739 (View on PubMed)

Kulvatunyou N, Bauman ZM, Zein Edine SB, de Moya M, Krause C, Mukherjee K, Gries L, Tang AL, Joseph B, Rhee P. The small (14 Fr) percutaneous catheter (P-CAT) versus large (28-32 Fr) open chest tube for traumatic hemothorax: A multicenter randomized clinical trial. J Trauma Acute Care Surg. 2021 Nov 1;91(5):809-813. doi: 10.1097/TA.0000000000003180.

Reference Type: DERIVED

PMID: 33843831 (View on PubMed)

Other Identifiers

1506936985A001

Identifier Type: -

Identifier Source: org_study_id