Rib Fracture Multiple, Trauma Chest
Conditions
Brief summary
The purpose of this study is to compare the usual care alone to usual care plus early surgical stabilization in adult trauma patients who have been admitted with rib fractures, to evaluate for heterogeneity of treatment effect in high risk subgroups and to determine the the impact of multiple rib fractures on post-discharge health status and time to return to work or usual physical activity.
Interventions
PROCEDUREsurgical stabilization
Surgical procedure utilizing any commercially available internal rib fixation system
PROCEDUREUsual care
Usual care typically consists of breathing exercises and pain control,often including opioids
Sponsors
National Center for Advancing Translational Sciences (NCATS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Blunt trauma mechanism * Severe chest wall injury (defined by one of the 3 below): Radiographic flail segment (defined as greater than 2 fractures in greater than 3 consecutive ribs) or greater than 5 consecutive rib fractures or greater than 1 rib fractures with bicortical displacement * At least one true rib (1-7) fractured and accessible for stabilization
Exclusion criteria
* Severe traumatic brain injury (best resuscitated GCS less than 8 as measured at 24 hours) * Spinal cord injury * Pre-existing congestive heart failure or oxygen-dependent pulmonary disease * Any reason for which SSRF could not occur within 72 hours of admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | 180 days after admission | Number of days patient is in the hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours | 24 hours after hospital admission | number of patients who require mechanical ventilation greater than 24 hours |
| Number of Patients Requiring Tracheostomy | Hospital discharge (about 20 to 30 days) | Number of patients requiring a tracheostomy due to prolonged mechanical ventilation |
| Number of Patients Who Developed Pneumonia During the Hospitalization | 6 months after admission | Number of patients diagnosed with pneumonia with greater than 10,000 cfu/ml on bronchioalveolar lavage or clinical diagnosis of pneumonia with subsequent antibiotic coverage |
| Number of Patients Who Received Regional Analgesia | 6 months after admission | Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia |
| Opioid Usage | Baseline | Opioid usage is reported in milligrams per patient pre-randomization |
| Ventilator Free Days | Hospital discharge (about 20 to 30 days) | Number of inpatient hospital days patients did not require mechanical ventilation |
| Intensive Care Unit (ICU) Free Days | Hospital discharge (about 20 to 30 days) | Number of inpatient hospital days patient was not in ICU in the first 30 days |
| Hospital (ICU) Free Days | 30 days post admission | Number of days patient was not in the hospital during the first 30 days after admission. |
| Mortality | 180 days after admission | Death following trauma injury involving rib fractures |
| Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 30 days post admission | Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome. |
| Health Status as Assessed by Index Score on the Euroqol-5D-5L | 30 days post admission | Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome. |
| Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | 30 days post admission | Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain, Anxiety) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome. |
| Time From Injury to Return to Work | 180 days post admission | Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment |
| Time From Injury to Resolution of Pain | 180 days post admission | Number of days from time of injury to time patient verbalized pain was resolved |
| Time From Injury to Return to Usual Activity | 180 days post admission | Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment |
| Number of Participants Prescribed Opioids at Discharge | Hospital discharge (about 20 to 30 days) | — |
| Number of Participants Back to Work or Normal Physical Activity | 30 days post admission | — |
| Re-intervention Rates for Surgical Complications | 180 days post admission | The number of times a procedure was required to treat surgical complications |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Surgical Stabilization This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management.
surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system | 42 |
| Usual Care This arm will be usual care only. Usual care will include pain managment.
Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids | 42 |
| Total | 84 |
Baseline characteristics
| Characteristic | Early Surgical Stabilization | Usual Care | Total |
|---|---|---|---|
| Abbreviated Injury Score Abdomen | 1 score on a scale | 0 score on a scale | 0 score on a scale |
| Abbreviated Injury Score Chest | 3 score on a scale | 3 score on a scale | 3 score on a scale |
| Abbreviated Injury Score External | 0 score on a scale | 0 score on a scale | 0 score on a scale |
| Abbreviated Injury Score Extremity | 2 score on a scale | 2 score on a scale | 2 score on a scale |
| Abbreviated Injury Score Face | 0 score on a scale | 0 score on a scale | 0 score on a scale |
| Abbreviated Injury Score Head | 1.5 score on a scale | 1 score on a scale | 1 score on a scale |
| Age, Continuous | 50 years STANDARD_DEVIATION 15 | 49 years STANDARD_DEVIATION 15 | 49.5 years STANDARD_DEVIATION 15 |
| Allocation Unit Intensive Care | 12 Participants | 12 Participants | 24 Participants |
| Allocation Unit Intermediate Care | 16 Participants | 15 Participants | 31 Participants |
| Allocation Unit Ward | 14 Participants | 15 Participants | 29 Participants |
| Body Mass Index | 31 kg/m^2 STANDARD_DEVIATION 6 | 30 kg/m^2 STANDARD_DEVIATION 6 | 30.5 kg/m^2 STANDARD_DEVIATION 6 |
| Emergency Department Diastolic Blood Pressure | 79 mmHg STANDARD_DEVIATION 19 | 79 mmHg STANDARD_DEVIATION 16 | 79 mmHg STANDARD_DEVIATION 17.5 |
| Emergency Department Glasgow Coma Scale Score | 15 score on a scale | 15 score on a scale | 15 score on a scale |
| Emergency Department Heart Rate | 93 beats per minute STANDARD_DEVIATION 22 | 93 beats per minute STANDARD_DEVIATION 18 | 93 beats per minute STANDARD_DEVIATION 20 |
| Emergency Department Respiratory Rate | 21 breaths per minute STANDARD_DEVIATION 5 | 20 breaths per minute STANDARD_DEVIATION 5 | 20.5 breaths per minute STANDARD_DEVIATION 5 |
| Emergency Department Systolic Blood Pressure | 125 mmHg STANDARD_DEVIATION 30 | 127 mmHg STANDARD_DEVIATION 35 | 126 mmHg STANDARD_DEVIATION 32.5 |
| Height | 174 centimeters STANDARD_DEVIATION 10 | 175 centimeters STANDARD_DEVIATION 10 | 174.5 centimeters STANDARD_DEVIATION 10 |
| Injury Severity Score | 22 score on a scale | 22 score on a scale | 22 score on a scale |
| Number of Participants Transferred From Another Institution | 15 Participants | 19 Participants | 34 Participants |
| Number of Participants Who Sustained Injury From a Fall | 3 Participants | 6 Participants | 9 Participants |
| Number of Participants Who Sustained Injury From a Motorcycle Collision | 7 Participants | 5 Participants | 12 Participants |
| Number of Participants Who Sustained Injury From a Motor Vehicle Collision | 24 Participants | 19 Participants | 43 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 6 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian, Hispanic | 7 Participants | 9 Participants | 16 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian, non-Hispanic | 29 Participants | 25 Participants | 54 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 42 participants | 42 participants | 84 participants |
| Sex: Female, Male Female | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 28 Participants | 31 Participants | 59 Participants |
| Time from arrival to randomizarion | 50 hours STANDARD_DEVIATION 22 | 54 hours STANDARD_DEVIATION 28 | 52 hours STANDARD_DEVIATION 25.1 |
| Weight | 95 kilograms STANDARD_DEVIATION 25 | 93 kilograms STANDARD_DEVIATION 22 | 94 kilograms STANDARD_DEVIATION 23.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 6 / 42 | 2 / 42 |
| serious Total, serious adverse events | 12 / 42 | 8 / 42 |
Outcome results
Primary
Hospital Length of Stay
Number of days patient is in the hospital
Time frame: 180 days after admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Surgical Stabilization | Hospital Length of Stay | 9 days |
| Usual Care | Hospital Length of Stay | 6 days |
Secondary
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.
Time frame: 90 days post admission
Population: Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.56 score on a scale | Standard Deviation 0.32 |
| Usual Care | Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.61 score on a scale | Standard Deviation 0.36 |
Secondary
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.
Time frame: 180 days post admission
Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.69 score on a scale | Standard Deviation 0.32 |
| Usual Care | Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.77 score on a scale | Standard Deviation 0.26 |
Secondary
Health Status as Assessed by Index Score on the Euroqol-5D-5L
Health Status will be assessed by the index score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L index score ranges from 0 (a state as bad as being dead) to 1 (full health), and it is a summary score based on societal preference weights for the cumulative health states measured by 5 different dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression). It is calculated using the 2017 United States time trade-off valuation data set. A higher score indicates a better outcome.
Time frame: 30 days post admission
Population: Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.44 score on a scale | Standard Deviation 0.34 |
| Usual Care | Health Status as Assessed by Index Score on the Euroqol-5D-5L | 0.53 score on a scale | Standard Deviation 0.27 |
Secondary
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.
Time frame: 30 days post admission
Population: Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 65 score on a scale | Standard Deviation 22 |
| Usual Care | Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 67 score on a scale | Standard Deviation 18 |
Secondary
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.
Time frame: 180 days post admission
Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 74 score on a scale | Standard Deviation 23 |
| Usual Care | Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 77 score on a scale | Standard Deviation 20 |
Secondary
Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)
Health status will be assessed by the Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). The Euro QoL 5-D 5-L VAS score is directly reported by participants and ranges from 0 (the worst imaginable health) to 100 (the best imaginable health). A higher score indicates a better outcome.
Time frame: 90 days post admission
Population: Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 69 score on a scale | Standard Deviation 24 |
| Usual Care | Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L) | 73 score on a scale | Standard Deviation 23 |
Secondary
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain, Anxiety) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.
Time frame: 30 days post admission
Population: Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Self-care | 2 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Pain | 3 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Usual activities | 3 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Anxiety | 2 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Mobility | 3 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Anxiety | 2 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Mobility | 2 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Self-care | 2 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Usual activities | 3 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Pain | 3 score on a scale |
Secondary
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.
Time frame: 180 days post admission
Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Self-care | 1 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Pain | 2 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Usual activities | 2 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Anxiety | 1 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Mobility | 1 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Anxiety | 1 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Mobility | 1 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Self-care | 1 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Usual activities | 1.5 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Pain | 2 score on a scale |
Secondary
Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L
Level of impairment will be assessed for five dimensions (Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression) by using the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L). Each dimension is rated at five levels: no impairment (1); minor impairment (2); moderate impairment (3); severe impairment (4); and extreme impairment (5). A higher score indicates a worse outcome.
Time frame: 90 days post admission
Population: Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Self-care | 1 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Pain | 3 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Usual activities | 3 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Anxiety | 2 score on a scale |
| Early Surgical Stabilization | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Mobility | 2 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Anxiety | 2 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Mobility | 1 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Self-care | 1 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Usual activities | 2 score on a scale |
| Usual Care | Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L | Pain | 2 score on a scale |
Secondary
Hospital (ICU) Free Days
Number of days patient was not in the hospital during the first 30 days after admission.
Time frame: 30 days post admission
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Surgical Stabilization | Hospital (ICU) Free Days | 21 days |
| Usual Care | Hospital (ICU) Free Days | 24 days |
Secondary
Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours
number of patients who require mechanical ventilation greater than 24 hours
Time frame: 24 hours after hospital admission
Population: Data were not collected for this outcome measure
Secondary
Intensive Care Unit (ICU) Free Days
Number of inpatient hospital days patient was not in ICU in the first 30 days
Time frame: Hospital discharge (about 20 to 30 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Surgical Stabilization | Intensive Care Unit (ICU) Free Days | 30 days |
| Usual Care | Intensive Care Unit (ICU) Free Days | 30 days |
Secondary
Mortality
Death following trauma injury involving rib fractures
Time frame: 180 days after admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Surgical Stabilization | Mortality | 0 Participants |
| Usual Care | Mortality | 0 Participants |
Secondary
Number of Participants Back to Work or Normal Physical Activity
Time frame: 90 days post admission
Population: Data were not collected for 8 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Surgical Stabilization | Number of Participants Back to Work or Normal Physical Activity | 14 Participants |
| Usual Care | Number of Participants Back to Work or Normal Physical Activity | 17 Participants |
Secondary
Number of Participants Back to Work or Normal Physical Activity
Time frame: 30 days post admission
Population: Data were not collected for 5 in the early surgical stabilization arm, and data were not collected for 7 in the usual care arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Surgical Stabilization | Number of Participants Back to Work or Normal Physical Activity | 5 Participants |
| Usual Care | Number of Participants Back to Work or Normal Physical Activity | 5 Participants |
Secondary
Number of Participants Back to Work or Normal Physical Activity
Time frame: 180 days post admission
Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Surgical Stabilization | Number of Participants Back to Work or Normal Physical Activity | 19 Participants |
| Usual Care | Number of Participants Back to Work or Normal Physical Activity | 19 Participants |
Secondary
Number of Participants Prescribed Opioids at Discharge
Time frame: Hospital discharge (about 20 to 30 days)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Surgical Stabilization | Number of Participants Prescribed Opioids at Discharge | Tramadol | 22 Participants |
| Early Surgical Stabilization | Number of Participants Prescribed Opioids at Discharge | Other Opioid | 3 Participants |
| Usual Care | Number of Participants Prescribed Opioids at Discharge | Tramadol | 24 Participants |
| Usual Care | Number of Participants Prescribed Opioids at Discharge | Other Opioid | 4 Participants |
Secondary
Number of Patients Requiring Tracheostomy
Number of patients requiring a tracheostomy due to prolonged mechanical ventilation
Time frame: Hospital discharge (about 20 to 30 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Surgical Stabilization | Number of Patients Requiring Tracheostomy | 7 Participants |
| Usual Care | Number of Patients Requiring Tracheostomy | 2 Participants |
Secondary
Number of Patients Who Developed Pneumonia During the Hospitalization
Number of patients diagnosed with pneumonia with greater than 10,000 cfu/ml on bronchioalveolar lavage or clinical diagnosis of pneumonia with subsequent antibiotic coverage
Time frame: 6 months after admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Surgical Stabilization | Number of Patients Who Developed Pneumonia During the Hospitalization | 9 Participants |
| Usual Care | Number of Patients Who Developed Pneumonia During the Hospitalization | 5 Participants |
Secondary
Number of Patients Who Received Regional Analgesia
Number of patients utilizing regional analgesia, such as epidural, paravertebral, intercostal or serratus plane anesthesia
Time frame: 6 months after admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Surgical Stabilization | Number of Patients Who Received Regional Analgesia | 7 Participants |
| Usual Care | Number of Patients Who Received Regional Analgesia | 3 Participants |
Secondary
Opioid Usage
Opioid usage is reported in milligrams per patient pre-randomization
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Surgical Stabilization | Opioid Usage | 80 milligrams |
| Usual Care | Opioid Usage | 79 milligrams |
Secondary
Opioid Usage
Opioid usage is reported in milligrams per patient from admission to discharge
Time frame: Hospital discharge (about 20 to 30 days)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Early Surgical Stabilization | Opioid Usage | Daily non-anesthesia opioid exposure | 20 milligrams |
| Early Surgical Stabilization | Opioid Usage | Opioid usage (non-anesthesia) | 203 milligrams |
| Early Surgical Stabilization | Opioid Usage | Opioid usage (all) | 349 milligrams |
| Early Surgical Stabilization | Opioid Usage | Opioid usage (anesthesia) | 149 milligrams |
| Usual Care | Opioid Usage | Daily non-anesthesia opioid exposure | 19 milligrams |
| Usual Care | Opioid Usage | Opioid usage (anesthesia) | 0 milligrams |
| Usual Care | Opioid Usage | Opioid usage (all) | 177 milligrams |
| Usual Care | Opioid Usage | Opioid usage (non-anesthesia) | 125 milligrams |
Secondary
Re-intervention Rates for Surgical Complications
The number of times a procedure was required to treat surgical complications
Time frame: 180 days post admission
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Early Surgical Stabilization | Re-intervention Rates for Surgical Complications | Seroma | 1 Participants |
| Early Surgical Stabilization | Re-intervention Rates for Surgical Complications | Surgical Site Infection | 1 Participants |
| Usual Care | Re-intervention Rates for Surgical Complications | Seroma | 0 Participants |
| Usual Care | Re-intervention Rates for Surgical Complications | Surgical Site Infection | 0 Participants |
Secondary
Time From Injury to Resolution of Pain
Number of days from time of injury to time patient verbalized pain was resolved
Time frame: 180 days post admission
Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Surgical Stabilization | Time From Injury to Resolution of Pain | 76 days |
| Usual Care | Time From Injury to Resolution of Pain | 54 days |
Secondary
Time From Injury to Return to Usual Activity
Number of days from time of injury until patient was able to return to usual activities prior to injury per patient's assessment
Time frame: 180 days post admission
Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Surgical Stabilization | Time From Injury to Return to Usual Activity | 92 days |
| Usual Care | Time From Injury to Return to Usual Activity | 67 days |
Secondary
Time From Injury to Return to Work
Number of days from time of injury until patient was able to return to work prior to injury per patient's assessment
Time frame: 180 days post admission
Population: Data were not collected for 6 in the early surgical stabilization arm, and data were not collected for 10 in the usual care arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Early Surgical Stabilization | Time From Injury to Return to Work | 48 days |
| Usual Care | Time From Injury to Return to Work | 43 days |
Secondary
Ventilator Free Days
Number of inpatient hospital days patients did not require mechanical ventilation
Time frame: Hospital discharge (about 20 to 30 days)
Population: Data were not collected for this outcome measure.