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This is a multicenter randomized study investigating the differences in clinical outcomes of patients between two standard of care pathways for rib trauma: patients who receive rib fixation versus patients who receive modern critical care and pain control after sustaining clinically significant rib fractures from trauma.
This study will compare the outcomes of patients between two standard of care pathways for rib trauma: those who have their ribs plated versus those who are managed by modern critical care and pain control. A study nurse (project) coordinator will identify subjects based on inclusion and exclusion criteria, then obtain consent for each of these patients prior to randomization. Randomization will be decided by a web-based computer program, accessible to the project coordinator. Although this randomization occurs, the study itself is purely observational, as the intervention is currently standard of care. None of the subjects or study group members will be blinded since it is not possible to disguise the intervention. Patients will be evaluated and a survey will be administered at set post-intervention intervals to determine endpoints and quality of life when data analysis will also take place.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rib Fixation System | Active Comparator | This group of subjects will receive a surgical rib plating procedure after trauma |
|
| Critical Care and Pain Control | No Intervention | This group will receive critical care and pain control after trauma |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rib Fixation System | Device | This intervention involves a surgical procedure to affix rib plates to broken ribs |
|
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of Stay | length of stay in days | measured through study completion, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life, as determined by SF-36 survey | measured at 3 different time points post-hospital stay | measured at 1 week, 3 months, 6 months post-intervention |
| Number of participants with pneumonia as defined by the Centers for Disease Control |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rates | including, but not limited to, pneumonia, urinary tract infection, arrhythmia, sepsis, reintubation, wound infection | measured at 1 week, 3 months, 6 months |
| Pain Control documented by the Functional Pain Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna Nayduch, RN, MSN | Contact | 352-401-1022 | donna.nayduch@hcahealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Darwin Ang, MD | HCA Trauma Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Walton Beach Medical Center | Active, not recruiting | Fort Walton Beach | Florida | 32547 | United States | |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| D005409 | Flail Chest |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D013898 | Thoracic Injuries |
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based on classification as complication of rib trauma treatment
| measured monthly through course of study, up to 2 years |
| Total cost of treatments | measured based on total costs during length of hospital stay | measured through study completion, up to 2 years |
measured using the Functional Pain Scale
| measured before and after surgery and at time of discharge, through study completion, up to 2 years |
| Ventilator/Ventilator Free Days | measured in days on or off ventilation, based on length of stay in hospital | measured through study completion, up to 2 years |
| Narcotic usage | converted to units of morphine | measured at 1 week, 3 months, 6 months |
| Hospital length of stay | measured in days | measured through study completion, up to 2 years |
| Pulmonary Function | as measured by FVC (forced vital capacity), FEV1, and TLC by spirometry | measured at discharge, 3 months, and 6 months, through study completion, up to 2 years |
| Time to wean from ventilator | measured in days | measured through study completion, up to 2 years |
| Tracheostomy rates | overall rate of tracheostomy in population | measured at 1 week, 3 months, 6 months |
| Lawnwood Regional Medical Center |
| Recruiting |
| Ft. Pierce |
| Florida |
| 34950 |
| United States |
|
| Osceola Regional Medical Center | Active, not recruiting | Kissimmee | Florida | 34741 | United States |
| Kendall Regional Medical Center | Recruiting | Miami | Florida | 33175 | United States |
|
| Ocala Regional Medical Center - Health Trauma | Recruiting | Ocala | Florida | 34471 | United States |
|
| Orange Park Medical Center | Active, not recruiting | Orange Park | Florida | 32073 | United States |
| Central Florida Regional Hospital | Recruiting | Sanford | Florida | 32771 | United States |
|
| Research Medical Center | Active, not recruiting | Kansas City | Missouri | 64132 | United States |
| Grand Strand Regional Medical Center | Recruiting | Myrtle Beach | South Carolina | 29572 | United States |
|
| Chippenham Johnston-Willis Hospital | Recruiting | Richmond | Virginia | 23225 | United States |
|