search
Back to results

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

Primary Purpose

Hemothorax, Hemopneumothorax; Traumatic, Empyema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chest tube placement
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemothorax focused on measuring Chest tube size, Hemothorax, Empyema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

28 French chest tube for hemothorax

14 French chest tube for hemothorax

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2017
Last Updated
March 6, 2023
Sponsor
Wake Forest University Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT03167723
Brief Title
Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
Official Title
Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemothorax, Hemopneumothorax; Traumatic, Empyema, Chest Tube Size
Keywords
Chest tube size, Hemothorax, Empyema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Investigator masked to outcomes data.
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
28 French chest tube for hemothorax
Arm Type
Experimental
Arm Description
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Arm Title
14 French chest tube for hemothorax
Arm Type
Experimental
Arm Description
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Intervention Type
Device
Intervention Name(s)
Chest tube placement
Intervention Description
Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
Primary Outcome Measure Information:
Title
Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention
Description
Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Duration of Chest Tube Placement.
Description
Number of days with chest tube placement
Time Frame
90 days
Title
Number of Participants Stratified by Length of Hospitalization Stay
Description
Number of weeks spent in hospital
Time Frame
90 days
Title
Change in Subjective Pain Scores From Baseline at 90 Days
Description
Assessed with 0-10 numeric pain rating scale - the higher the number, the more severe the pain
Time Frame
90 days
Title
Hemodynamic Stability Post-insertion
Description
determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure <90mm Hg)
Time Frame
90 days
Title
Initial Drainage From Chest Tube at 5 Minutes
Description
Milliliters of chest tube drainage at 5 minutes
Time Frame
5 Minutes
Title
Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration
Description
Number of Tube specific complications: Air leak, tube malposition, & tube migration
Time Frame
90 days
Title
Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax
Description
Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
Time Frame
90 days
Title
Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal
Description
Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
Time Frame
90 days
Title
Readmission for Chest Tube Related Complications
Description
Number of Participants readmitted for chest tube related complications
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley W Thomas, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18716687
Citation
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.
Results Reference
background
PubMed Identifier
22327984
Citation
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.
Results Reference
result
PubMed Identifier
24375295
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs