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

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.

Study Overview

• Status: Completed
• Conditions: Hemothorax; Empyema; Hemopneumothorax; Traumatic; Chest Tube Size
• Intervention / Treatment: Device: Chest tube placement

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Publications and helpful links

General Publications

• Kulvatunyou N, Erickson L, Vijayasekaran A, Gries L, Joseph B, Friese RF, O'Keeffe T, Tang AL, Wynne JL, Rhee P. Randomized clinical trial of pigtail catheter versus chest tube in injured patients with uncomplicated traumatic pneumothorax. Br J Surg. 2014 Jan;101(2):17-22. doi: 10.1002/bjs.9377.
• Karmy-Jones R, Holevar M, Sullivan RJ, Fleisig A, Jurkovich GJ. Residual hemothorax after chest tube placement correlates with increased risk of empyema following traumatic injury. Can Respir J. 2008 Jul-Aug;15(5):255-8. doi: 10.1155/2008/918951.
• Inaba K, Lustenberger T, Recinos G, Georgiou C, Velmahos GC, Brown C, Salim A, Demetriades D, Rhee P. Does size matter? A prospective analysis of 28-32 versus 36-40 French chest tube size in trauma. J Trauma Acute Care Surg. 2012 Feb;72(2):422-7. doi: 10.1097/TA.0b013e3182452444.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Hemothorax; Empyema; Chest tube size
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Inflammation; Pleural Diseases; Hemorrhage; Suppuration; Hemothorax; Empyema; Hemopneumothorax
• Other Study ID Numbers: IRB00081328; Pro00020984 (Other Identifier: Atrium Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No