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

Study Overview
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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.

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

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

Intervention / Treatment
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* Device: Chest tube placement


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 28 French chest tube for hemothorax<br>28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax | Device: Chest tube placement<br>* Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.<br>|
| Experimental: 14 French chest tube for hemothorax<br>14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax | Device: Chest tube placement<br>* Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention | Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Chest Tube Placement. | Number of days with chest tube placement | 90 days | 
| Number of Participants Stratified by Length of Hospitalization Stay | Number of weeks spent in hospital | 90 days | 
| Change in Subjective Pain Scores From Baseline at 90 Days | Assessed with 0-10 numeric pain rating scale - the higher the number, the more severe the pain | 90 days | 
| Hemodynamic Stability Post-insertion | determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure <90mm Hg) | 90 days | 
| Initial Drainage From Chest Tube at 5 Minutes | Milliliters of chest tube drainage at 5 minutes | 5 Minutes | 
| Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration | Number of Tube specific complications: Air leak, tube malposition, & tube migration | 90 days | 
| Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax | Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax | 90 days | 
| Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal | Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal | 90 days | 
| Readmission for Chest Tube Related Complications | Number of Participants readmitted for chest tube related complications | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest tube size, Hemothorax, Empyema