An interventional study of Chest tube placement in Hemothorax, Hemopneumothorax; Traumatic and Empyema, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Device: Chest tube placement
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.
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.
Time frame: 90 days
Duration of Chest Tube Placement.
Number of days with chest tube placement
Time frame: 90 days
Number of Participants Stratified by Length of Hospitalization Stay
Number of weeks spent in hospital
Time frame: 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
Time frame: 90 days
Hemodynamic Stability Post-insertion
determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure \<90mm Hg)
Time frame: 90 days
Initial Drainage From Chest Tube at 5 Minutes
Milliliters of chest tube drainage at 5 minutes
Time frame: 5 Minutes
Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration
Number of Tube specific complications: Air leak, tube malposition, \& tube migration
Time frame: 90 days
Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax
Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
Time frame: 90 days
Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal
Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
Time frame: 90 days
Readmission for Chest Tube Related Complications
Number of Participants readmitted for chest tube related complications
Time frame: 90 days
| Milestone | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Started | 55 | 54 |
| Completed | 51 | 48 |
| Not completed | 4 | 6 |
| Withdrew: Protocol violation | 4 | 6 |
Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.
| Number of Participants | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention | 51 | 48 |
Number of days with chest tube placement
| days | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Duration of Chest Tube Placement. | 3.9 (2.6 to 5.3) | 3.9 (2.8 to 5.8) |
Number of weeks spent in hospital
| Number of Participants | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| 1 Week | 20 | 15 |
| 2 Weeks | 19 | 15 |
| 3 Weeks | 7 | 6 |
| > or = 4 Weeks | 5 | 12 |
Assessed with 0-10 numeric pain rating scale - the higher the number, the more severe the pain
| units on a scale | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Change in Subjective Pain Scores From Baseline at 90 Days | 0 (-1 to 2) | 0 (-2 to 2) |
determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure \<90mm Hg)
| Number of Participants | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Hemodynamic Stability Post-insertion | 2 | 1 |
Milliliters of chest tube drainage at 5 minutes
| mL | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Initial Drainage From Chest Tube at 5 Minutes | 150 (60 to 500) | 100 (3.5 to 350) |
Number of Tube specific complications: Air leak, tube malposition, \& tube migration
| Ocurrences | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration | 7 | 5 |
Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
| days | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax | 0.5 (0.1 to 2.7) | 1 (0.1 to 2.7) |
Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
| participants | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal | 5 | 1 |
Number of Participants readmitted for chest tube related complications
| participants | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax |
|---|---|---|
| Readmission for Chest Tube Related Complications | 9 | 4 |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 28 French Chest Tube for Hemothorax | 2/55 (3.6%) | 0/55 (0%) | 0/55 (0%) |
| 14 French Chest Tube for Hemothorax | 2/54 (3.7%) | 0/54 (0%) | 0/54 (0%) |
| Age, Continuous(years) | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax | Total |
|---|---|---|---|
| Median | 49.9 (33.6 to 72.4) | 46.5 (26.8 to 68.6) | 49 (26.5 to 72) |
| Sex: Female, Male(Participants) | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax | Total |
|---|---|---|---|
| Female | 17 | 15 | 32 |
| Male | 38 | 39 | 77 |
| Race and Ethnicity Not Collected(Participants) | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Injury Severity Score - score that ranges from 3 (least) to 75 (most) injured(units on a scale) | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax | Total |
|---|---|---|---|
| Median | 17 (13 to 29) | 18 (10 to 29) | 17 (10 to 29) |
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Wake Forest University Health Sciences