NCT03167723

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemothorax
• Hemopneumothorax; Traumatic
• Empyema
• Chest Tube Size

Interventions

Type	Name	Description
DEVICE	Chest tube placement	Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.

Timeline

• Start date: 2017-05-08
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2017-05-30
• Last updated: 2023-03-29
• Results posted: 2023-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study