Clinical trial NCT03167723: Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
Official title: Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemothorax
Hemopneumothorax; Traumatic
Empyema
Chest Tube Size
Keywords: Chest tube size
Hemothorax
Empyema
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traumatic hemothorax and hemopneumothorax are common diagnoses which are typically treated by placement of a chest tube. 28-32 Fr chest tubes have previously been shown equivalent to 36-40 Fr chest tubes for the non-emergent drainage of hemothorax. A smaller study has found 14 Fr pigtails had less pain than larger tubes but was not powered to compare outcomes. We seek to perform a prospective randomized trial that is adequately powered comparing efficacy of 14 Fr thal tubes to 28 Fr chest tubes for non-emergent drainage of hemothorax and hemopneumothorax. Additionally, we will employ maximal barrier precautions for all chest tube insertions and compare empyema rates to our historical controls.


Eligibility criteria: Inclusion Criteria:

* The patient is admitted to the trauma service.
* The patient has a hemothorax and/or or hemopneumothorax, requiring thoracostomy tube placement.
* Thoracostomy tube placement is able to be performed or witnessed by an investigator listed on the study.
* The patient has not had a chest tube in the past year.
* The patient is \>18 years of age.
* In the event the patient is decisionally impaired, consent will be obtained from the individual's legally authorized representative (LAR) or from the individual's healthcare power of attorney (HPA).
* In the instance of reversible impairment, initial consent would be obtained from the LAR/HPA and the patient will be approached for consent once he/she is deemed mentally competent by the care provider.

Exclusion Criteria:

* The patient is incarcerated
* The patient is known to be pregnant
* The patient is \< 18 years of age
* The patient is hemodynamically unstable, requiring emergent chest tube placement (in \<10 minutes from evaluation).

Primary outcomes:
measure: Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention
timeFrame: 90 days
Secondary outcomes:
measure: Duration of Chest Tube Placement.
timeFrame: 90 days
measure: Number of Participants Stratified by Length of Hospitalization Stay
timeFrame: 90 days
measure: Change in Subjective Pain Scores From Baseline at 90 Days
timeFrame: 90 days
measure: Hemodynamic Stability Post-insertion
timeFrame: 90 days
measure: Initial Drainage From Chest Tube at 5 Minutes
timeFrame: 5 Minutes
measure: Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration
timeFrame: 90 days
measure: Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax
timeFrame: 90 days
measure: Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal
timeFrame: 90 days
measure: Readmission for Chest Tube Related Complications
timeFrame: 90 days
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Bradley W Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karmy-Jones R, Holevar M, Sullivan RJ, Fleisig A, Jurkovich GJ. Residual hemothorax after chest tube placement correlates with increased risk of empyema following traumatic injury. Can Respir J. 2008 Jul-Aug;15(5):255-8. doi: 10.1155/2008/918951.
citation: Inaba K, Lustenberger T, Recinos G, Georgiou C, Velmahos GC, Brown C, Salim A, Demetriades D, Rhee P. Does size matter? A prospective analysis of 28-32 versus 36-40 French chest tube size in trauma. J Trauma Acute Care Surg. 2012 Feb;72(2):422-7. doi: 10.1097/TA.0b013e3182452444.
citation: 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.