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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00020984 | Other Identifier | Atrium Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 28 French chest tube for hemothorax | Experimental | 28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax |
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| 14 French chest tube for hemothorax | Experimental | 14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest tube placement | Device | Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley W Thomas, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18716687 | Background | 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. | |
| 22327984 | Result | 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. |
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Excluded (n=84) Hemodynamic instability (n=36) Chest tube placed at outside facility (n=12) Multiple chest tube placement (n=10) Declined to participate (n=1) Not meet inclusion criteria (n=6) Other reasons (n=19)
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| ID | Title | Description |
|---|---|---|
| FG000 | 28 French Chest Tube for Hemothorax | 28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions. |
| FG001 | 14 French Chest Tube for Hemothorax |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2017 |
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Investigator masked to outcomes data.
| 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 |
| 24375295 | Result | 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. |
| 39700058 | Derived | McCartt 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. |
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 28 French Chest Tube for Hemothorax | 28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions. |
| BG001 | 14 French Chest Tube for Hemothorax | 14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Injury Severity Score - score that ranges from 3 (least) to 75 (most) injured | Specific injuries in each body region are coded on a scale of 1 (minor), 2 (moderate), 3 (serious, not life threatening), 4 (severe, life threatening, survival probable), 5 (critical, survival uncertain) and 6 (unsurvivable). | Median | Inter-Quartile Range | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Posted | Number | Number of Participants | 90 days |
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| Secondary | Duration of Chest Tube Placement. | Number of days with chest tube placement | Posted | Median | Inter-Quartile Range | days | 90 days |
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| Secondary | Number of Participants Stratified by Length of Hospitalization Stay | Number of weeks spent in hospital | Posted | Number | Number of Participants | 90 days |
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| Secondary | 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 | Posted | Median | Inter-Quartile Range | units on a scale | 90 days |
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| Secondary | Hemodynamic Stability Post-insertion | determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure <90mm Hg) | Posted | Number | Number of Participants | 90 days |
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| Secondary | Initial Drainage From Chest Tube at 5 Minutes | Milliliters of chest tube drainage at 5 minutes | Posted | Median | Inter-Quartile Range | mL | 5 Minutes |
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| Secondary | Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration | Number of Tube specific complications: Air leak, tube malposition, & tube migration | Posted | Number | Ocurrences | 90 days |
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| Secondary | Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax | Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax | Posted | Median | Inter-Quartile Range | days | 90 days |
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| Secondary | Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal | Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal | Posted | Number | participants | 90 days |
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| Secondary | Readmission for Chest Tube Related Complications | Number of Participants readmitted for chest tube related complications | Posted | Number | participants | 90 days |
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90 days
Participants will be monitored for serious adverse events from the moment of randomization through 90 days post tube insertion. Due to their mechanism of injury and high trauma burden, participants are expected to have significant trauma related complications. AEs or SAEs determined to be unrelated to study procedure or tube size will not be reported to the IRB. Submission of any serious adverse event will not occur until relatedness of the event has been determined.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 28 French Chest Tube for Hemothorax | 28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions. | 2 | 55 | 0 | 55 | 0 | 55 |
| EG001 | 14 French Chest Tube for Hemothorax | 14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions. | 2 | 54 | 0 | 54 | 0 | 54 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley Thomas MD | Atrium Health Wake Forest | 704-355-3176 | bradley.thomas@atriumhealth.org |
| Oct 30, 2017 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2017 | Dec 27, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006491 | Hemothorax |
| D006468 | Hemopneumothorax |
| D004653 | Empyema |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
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