HemothoraxNCT03167723
Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
A study testing Chest tube placement in people with Hemothorax and Hemopneumothorax; Traumatic, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemothorax, Hemopneumothorax; Traumatic, Empyema
- What is being tested?
- Chest tube placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2017to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
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.
- Conditions
- Hemothorax, Hemopneumothorax; Traumatic, Empyema, Chest Tube Size
- Being tested
- Chest tube placement
- Keywords
- Chest tube size, Hemothorax, Empyema
- Medical subject headings
- Hemothorax, Hemopneumothorax, Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest tube placementDevice
Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
| Study group | Role | What they receive |
|---|---|---|
| 28 French chest tube for hemothorax | Experimental | 28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax Receives: Device: Chest tube placement |
| 14 French chest tube for hemothorax | Experimental | 14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax Receives: Device: Chest tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (9)
Duration of Chest Tube Placement.
Number of days with chest tube placement
Measured: 90 days
Number of Participants Stratified by Length of Hospitalization Stay
Number of weeks spent in hospital
Measured: 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
Measured: 90 days
Hemodynamic Stability Post-insertion
determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure <90mm Hg)
Measured: 90 days
Initial Drainage From Chest Tube at 5 Minutes
Milliliters of chest tube drainage at 5 minutes
Measured: 5 Minutes
Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration
Number of Tube specific complications: Air leak, tube malposition, \& tube migration
Measured: 90 days
Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax
Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
Measured: 90 days
Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal
Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
Measured: 90 days
Readmission for Chest Tube Related Complications
Number of Participants readmitted for chest tube related complications
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start8 May 2017
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemothoraxStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley W Thomas, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167723
- Sponsor's protocol ID
- IRB00081328
- Other IDs
- Pro00020984
- Status last verified
- Aug 2022
- First submitted
- 24 May 2017
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18716687Inaba 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.
PubMed 22327984Kulvatunyou 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.
PubMed 24375295McCartt J, Ross SW, Cunningham KW, Wang H, Sealey L, Brake J, Christmas A, Sachdev G, Green J, Thomas BW. A Randomized Non-Inferiority Clinical Trial of 14Fr Thal versus 28Fr Tube Thoracostomy for Traumatic Hemothorax. Am Surg. 2025 Apr;91(4):579-586. doi: 10.1177/00031348241308907. Epub 2024 Dec 19.
PubMed 39700058
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
- ClinicalTrials.gov ID
- NCT03167723
- Acronym / sponsor ID
- IRB00081328
- Conditions
- Hemothorax, Hemopneumothorax; Traumatic, Empyema, Chest Tube Size
- Keywords
- Chest tube size, Hemothorax, Empyema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 28 French chest tube for hemothorax | Experimental | Device: Chest tube placement28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax |
| 14 French chest tube for hemothorax | Experimental | Device: Chest tube placement14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest tube placementPlacing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions. | Device | 14 French chest tube for hemothorax, 28 French chest tube for hemothorax |
Primary outcome
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.
9 secondary outcomes
Duration of Chest Tube Placement.
Time frame: 90 days
Number of Participants Stratified by Length of Hospitalization Stay
Time frame: 90 days
Change in Subjective Pain Scores From Baseline at 90 Days
Time frame: 90 days
Hemodynamic Stability Post-insertion
Time frame: 90 days
Initial Drainage From Chest Tube at 5 Minutes
Time frame: 5 Minutes
Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration
Time frame: 90 days
Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax
Time frame: 90 days
Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal
Time frame: 90 days
Readmission for Chest Tube Related Complications
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18716687Karmy-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 publication: PubMed 22327984Inaba 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 publication: PubMed 24375295Kulvatunyou 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.
- Derived from this study: PubMed 39700058McCartt J, Ross SW, Cunningham KW, Wang H, Sealey L, Brake J, Christmas A, Sachdev G, Green J, Thomas BW. A Randomized Non-Inferiority Clinical Trial of 14Fr Thal versus 28Fr Tube Thoracostomy for Traumatic Hemothorax. Am Surg. 2025 Apr;91(4):579-586. doi: 10.1177/00031348241308907. Epub 2024 Dec 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley W Thomas, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest tube placement in people with Hemothorax and Hemopneumothorax; Traumatic, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03167723, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.