Chest Tube Size, Empyema, Hemopneumothorax; Traumatic, Hemothorax
Conditions
Keywords
Chest tube size, Hemothorax, Empyema
Brief 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.
Interventions
DEVICEChest tube placement
Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Investigator masked to outcomes data.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Duration of Chest Tube Placement. | 90 days | Number of days with chest tube placement |
| 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 |
| Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration | 90 days | Number of Tube specific complications: Air leak, tube malposition, & tube migration |
Countries
United States
Participant flow
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 55 |
| 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. | 54 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 4 | 6 |
Baseline characteristics
| Characteristic | 28 French Chest Tube for Hemothorax | 14 French Chest Tube for Hemothorax | Total |
|---|---|---|---|
| Age, Continuous | 49.9 years | 46.5 years | 49 years |
| Injury Severity Score - score that ranges from 3 (least) to 75 (most) injured | 17 units on a scale | 18 units on a scale | 17 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 17 Participants | 15 Participants | 32 Participants |
| Sex: Female, Male Male | 38 Participants | 39 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 55 | 2 / 54 |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
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.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention | 51 Number of Participants |
| 14 French Chest Tube for Hemothorax | Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention | 48 Number of Participants |
p-value: 0.036Farrington-Manning
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
Time frame: 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Change in Subjective Pain Scores From Baseline at 90 Days | 0 units on a scale |
| 14 French Chest Tube for Hemothorax | Change in Subjective Pain Scores From Baseline at 90 Days | 0 units on a scale |
Secondary
Duration of Chest Tube Placement.
Number of days with chest tube placement
Time frame: 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Duration of Chest Tube Placement. | 3.9 days |
| 14 French Chest Tube for Hemothorax | Duration of Chest Tube Placement. | 3.9 days |
Secondary
Hemodynamic Stability Post-insertion
determined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure \<90mm Hg)
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Hemodynamic Stability Post-insertion | 2 Number of Participants |
| 14 French Chest Tube for Hemothorax | Hemodynamic Stability Post-insertion | 1 Number of Participants |
Secondary
Initial Drainage From Chest Tube at 5 Minutes
Milliliters of chest tube drainage at 5 minutes
Time frame: 5 Minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Initial Drainage From Chest Tube at 5 Minutes | 150 mL |
| 14 French Chest Tube for Hemothorax | Initial Drainage From Chest Tube at 5 Minutes | 100 mL |
Secondary
Number of Participants Stratified by Length of Hospitalization Stay
Number of weeks spent in hospital
Time frame: 90 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 28 French Chest Tube for Hemothorax | Number of Participants Stratified by Length of Hospitalization Stay | 3 Weeks | 7 Number of Participants |
| 28 French Chest Tube for Hemothorax | Number of Participants Stratified by Length of Hospitalization Stay | 1 Week | 20 Number of Participants |
| 28 French Chest Tube for Hemothorax | Number of Participants Stratified by Length of Hospitalization Stay | > or = 4 Weeks | 5 Number of Participants |
| 28 French Chest Tube for Hemothorax | Number of Participants Stratified by Length of Hospitalization Stay | 2 Weeks | 19 Number of Participants |
| 14 French Chest Tube for Hemothorax | Number of Participants Stratified by Length of Hospitalization Stay | > or = 4 Weeks | 12 Number of Participants |
| 14 French Chest Tube for Hemothorax | Number of Participants Stratified by Length of Hospitalization Stay | 3 Weeks | 6 Number of Participants |
| 14 French Chest Tube for Hemothorax | Number of Participants Stratified by Length of Hospitalization Stay | 2 Weeks | 15 Number of Participants |
| 14 French Chest Tube for Hemothorax | Number of Participants Stratified by Length of Hospitalization Stay | 1 Week | 15 Number of Participants |
Secondary
Readmission for Chest Tube Related Complications
Number of Participants readmitted for chest tube related complications
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Readmission for Chest Tube Related Complications | 9 participants |
| 14 French Chest Tube for Hemothorax | Readmission for Chest Tube Related Complications | 4 participants |
Secondary
Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal
Number of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal | 5 participants |
| 14 French Chest Tube for Hemothorax | Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal | 1 participants |
Secondary
Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax
Number of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
Time frame: 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax | 0.5 days |
| 14 French Chest Tube for Hemothorax | Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax | 1 days |
Secondary
Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration
Number of Tube specific complications: Air leak, tube malposition, & tube migration
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 28 French Chest Tube for Hemothorax | Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration | 7 Ocurrences |
| 14 French Chest Tube for Hemothorax | Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration | 5 Ocurrences |