| Registry | NCT03167723 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 193 (Actual) |
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| Sponsor | Wake Forest University Health Sciences (Other) |
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| Conditions | Hemothorax, Hemopneumothorax; Traumatic, Empyema, Chest Tube Size |
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| Interventions | Chest tube placement (Device) |
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| Dates | start 2017-05-08, primary completion 2021-12-20, completion 2021-12-20, first posted 2017-05-30, last updated 2023-03-29 |
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| Locations | 1 site in United States |
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All trials for Hemothorax All trials for Hemopneumothorax; Traumatic All trials of Chest tube placement
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| 28 French chest tube for hemothorax | Experimental | Device: Chest tube placement | 28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax |
| 14 French chest tube for hemothorax | Experimental | Device: Chest tube placement | 14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax |
- Chest tube placement (Device): Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
+Outcome measures
Primary outcomes
- Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention [90 days]: Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.
Secondary outcomes
- Duration of Chest Tube Placement. [90 days]: Number of days with chest tube placement
- Number of Participants Stratified by Length of Hospitalization Stay [90 days]: Number of weeks spent in hospital
- Change in Subjective Pain Scores From Baseline at 90 Days [90 days]: Assessed with 0-10 numeric pain rating scale - the higher the number, the more severe the pain
- Hemodynamic Stability Post-insertion [90 days]: determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure <90mm Hg)
- Initial Drainage From Chest Tube at 5 Minutes [5 Minutes]: Milliliters of chest tube drainage at 5 minutes
- Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration [90 days]: Number of Tube specific complications: Air leak, tube malposition, \& tube migration
- Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax [90 days]: Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
- Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal [90 days]: Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
- Readmission for Chest Tube Related Complications [90 days]: Number of Participants readmitted for chest tube related complications
+Eligibility
Sex: All, ages: 18 Years to any
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).
+Posted results
Participant flow
| Milestone | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|
| Started | 55 | 54 |
| Completed | 51 | 48 |
| Not completed | 4 | 6 |
Outcome results
- Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention (Primary), Number, Number of Participants: 28 French Chest Tube for Hemothorax 51; 14 French Chest Tube for Hemothorax 48 (p 0.036)
- Duration of Chest Tube Placement. (Secondary), Median, days: 28 French Chest Tube for Hemothorax 3.9 (2.6 to 5.3); 14 French Chest Tube for Hemothorax 3.9 (2.8 to 5.8)
- Number of Participants Stratified by Length of Hospitalization Stay (Secondary), Number, Number of Participants: 28 French Chest Tube for Hemothorax 20; 14 French Chest Tube for Hemothorax 15
- Change in Subjective Pain Scores From Baseline at 90 Days (Secondary), Median, units on a scale: 28 French Chest Tube for Hemothorax 0 (-1 to 2); 14 French Chest Tube for Hemothorax 0 (-2 to 2)
- Hemodynamic Stability Post-insertion (Secondary), Number, Number of Participants: 28 French Chest Tube for Hemothorax 2; 14 French Chest Tube for Hemothorax 1
- Initial Drainage From Chest Tube at 5 Minutes (Secondary), Median, mL: 28 French Chest Tube for Hemothorax 150 (60 to 500); 14 French Chest Tube for Hemothorax 100 (3.5 to 350)
- Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration (Secondary), Number, Ocurrences: 28 French Chest Tube for Hemothorax 7; 14 French Chest Tube for Hemothorax 5
- Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax (Secondary), Median, days: 28 French Chest Tube for Hemothorax 0.5 (0.1 to 2.7); 14 French Chest Tube for Hemothorax 1 (0.1 to 2.7)
- Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal (Secondary), Number, participants: 28 French Chest Tube for Hemothorax 5; 14 French Chest Tube for Hemothorax 1
- Readmission for Chest Tube Related Complications (Secondary), Number, participants: 28 French Chest Tube for Hemothorax 9; 14 French Chest Tube for Hemothorax 4
Adverse events
Time frame: 90 days
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| 28 French Chest Tube for Hemothorax | 2/55 (3.6%) | 0/55 (0.0%) | 0/55 (0.0%) |
| 14 French Chest Tube for Hemothorax | 2/54 (3.7%) | 0/54 (0.0%) | 0/54 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Carolinas Medical Center | Charlotte, North Carolina | United States | |
+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. PMID 18716687
- Results publication: 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. PMID 22327984
- Results publication: 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. PMID 24375295
- Results publication: 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. PMID 39700058
+Study documents
+Investigators