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

March 6, 2023 updated by: Wake Forest University Health Sciences
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention
Time Frame: 90 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of Chest Tube Placement.
Time Frame: 90 days
Number of days with chest tube placement
90 days
Number of Participants Stratified by Length of Hospitalization Stay
Time Frame: 90 days
Number of weeks spent in hospital
90 days
Change in Subjective Pain Scores From Baseline at 90 Days
Time Frame: 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
Time Frame: 90 days
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
Time Frame: 5 Minutes
Milliliters of chest tube drainage at 5 minutes
5 Minutes
Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration
Time Frame: 90 days
Number of Tube specific complications: Air leak, tube malposition, & tube migration
90 days
Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax
Time Frame: 90 days
Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
90 days
Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal
Time Frame: 90 days
Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
90 days
Readmission for Chest Tube Related Complications
Time Frame: 90 days
Number of Participants readmitted for chest tube related complications
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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