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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03546764
Acronym
P-CAT
Enrollment
61
Registered
2018-06-06
Start date
2018-03-01
Completion date
2021-02-01
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Percutatneous catheter, chest tube, trauma, hemothorax

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.

Interventions

tube inserted to drain hemothorax

Sponsors

Cook Group Incorporated
CollaboratorINDUSTRY
University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patient does not know the details of the treatment assignment

Intervention model description

Two arms - Percutaneous catheter arm vs Chest tube arm

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Failure rate30 daysFailure rate is defined as any second intervention to treat retained hemothorax

Secondary

MeasureTime frameDescription
Insertion-related complication30 daysany insertion-related complication, minor or major
Hospital course outcome30 daysICU length of stay, hospital length of stay

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026