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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-08

Study Completion Date

2021-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemothorax Hemopneumothorax; Traumatic Empyema Chest Tube Size

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Investigator masked to outcomes data.

Study Groups

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28 French chest tube for hemothorax

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

Group Type EXPERIMENTAL

Chest tube placement

Intervention Type DEVICE

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

14 French chest tube for hemothorax

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

Group Type EXPERIMENTAL

Chest tube placement

Intervention Type DEVICE

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

Interventions

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Chest tube placement

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

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No