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

NCT03167723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2023-03-29

Study results available
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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

DEVICE

Chest tube placement

Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Bradley W Thomas, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2021-12-20
Completion
2021-12-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03167723 on ClinicalTrials.gov