Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions

Wake Forest University (WFU)

Status: Completed

Conditions: Hemothorax; Hemopneumothorax; Traumatic; Empyema; Chest Tube Size

Treatments: Device: Chest tube placement

Study type: Interventional

Funder types: Other

Identifiers

NCT03167723

Pro00020984 (Other Identifier)

IRB00081328

Details and patient eligibility

About

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.

Enrollment: 193 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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193 participants in 2 patient groups

28 French chest tube for hemothorax

Experimental group

Description:

28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax

Treatment:

Device: Chest tube placement

14 French chest tube for hemothorax

Experimental group

Description:

14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax

Treatment:

Device: Chest tube placement