Comparing 14 F Pigtail Catheter to Traditional 28-32F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax

Sponsor

Narong Kulvatunyou (Other)

Overall Status

Unknown status

CT.gov ID

NCT02553434

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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). The treatment for these conditions include the insertion of a tube into the chest called a chest tube). Insertion of the chest tube is commonly very painful for the patient due to the size or diameter of the tube. Alternatively, procedure it is standard practice in the acute care setting at Banner-University of Arizona Tucson Campus (B-UATC) to insert a pigtail catheter, which has a smaller diameter, into the chest wall to treat the hemothorax or hemopnuemothorax. The primary purpose of this study is to see if the use of the pigtail catheter is just as effective as chest tube insertion in terms of removing leaked blood and/or air from the chest cavity. An additional objective of this study is to evaluate which procedure is less painful for the patient.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Hemothorax	Device: Pigtail catheter	Phase 3

Detailed Description

The standard treatment for traumatic hemothorax (HTX) and hemopneumothorax (HPTX) has been an insertion of a large-bore chest tube (CT) (French 28-32). The procedure is associated with significant patient's pain and discomfort. Investigator's institution has taken a lead role to replace chest tube insertion with 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 32-36F 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), investigator's division has inserted probably 100 PC for hemothorax and hemopneumohthorax Therefore, the investigators now believe that it is time for the investigator to demonstrate the efficacy of the PC for hemothorax with a prospective and randomized study as the investigator had done previously for traumatic pneumothorax (3).

The investigators hypothesize that pigtail catheter will be just as effective as the chest tube in patients with traumatic HTX and HPTX.

The investigators' study aim is to demonstrate the efficacy of the pigtail catheter in a prospective and randomized fashion as we have done previously in pneumothorax.

The investigators' primary end point is the success/failure rate. Failure is defined as a second intervention is required i.e., second tube, video-assisted thoracoscopy (VATS), etc.

The investigators' secondary end points are the amount of initial tube drainage, 24-hour, 48-hour, 72-hour; and complications, hospital length of stay, and chest tube or pigtail insertion experience as expressed by the patient.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Prospective and Randomized Study Comparing 14 F Pigtail Catheter to Traditional 32-36F Chest Tube in the Management of Traumatic Hemothorax and Hemopneumothorax

Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pigtail catheter (case) Inserting 14 French pigtail catheter	Device: Pigtail catheter Insertion of pigtail catheter Other Names: small-bore catheter
No Intervention: Chest tube inserting 32-36 French chest tube

Arm

Intervention/Treatment

Experimental: Pigtail catheter (case)

Inserting 14 French pigtail catheter

Device: Pigtail catheter

Insertion of pigtail catheter

Other Names:

small-bore catheter

No Intervention: Chest tube

inserting 32-36 French chest tube

Outcome Measures

Primary Outcome Measures

Number of participants with failure of initial intervention [1 year]
Requiring a second intervention i.e., second tube, VATS, etc

Secondary Outcome Measures

initial drainage (blood) output at the time of tube insertion [1 year]
the amount of blood that comes out when tube is placed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18
Traumatic hemothorax/HPTX requiring chest tube insertion (but not as an emergency)
Patient is conscious, GCS 14-15, and able to report tube insertion experience
English speaking subjects (we plan to have the consent translated in Spanish following approval)