Flail Chest, Rib Fracture
Conditions
Keywords
Trauma, Rib Plate, Rib Fixation
Brief summary
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.
Detailed description
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.
Interventions
DEVICERib Fixation System
This intervention involves a surgical procedure to affix rib plates to broken ribs
Sponsors
Darwin Ang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Flail chest, defined as 3 or more consecutive ribs fractured in more than one place * Pain and disability of an FPS (Functional Pain Scale) rating of 3 or higher * Deformity and Defect * Non-Union * Thoracotomy for other indications * 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter * Failure to wean from ventilator
Exclusion criteria
* Active bacteremia * Active shock * Severe Traumatic Brain Injury with GCS \< 8 * Age 17 years or less or age greater than 90 years old * Chronic pulmonary disease requiring home oxygenation * Acute Respiratory Distress Syndrome * Penetrating chest trauma * Chronic opioid dependence * Fractures less than 3cm from vertebral spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ICU Length of Stay | measured through study completion, up to 2 years | length of stay in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life, as determined by SF-36 survey | measured at 1 week, 3 months, 6 months post-intervention | measured at 3 different time points post-hospital stay |
| Number of participants with pneumonia as defined by the Centers for Disease Control | measured monthly through course of study, up to 2 years | based on classification as complication of rib trauma treatment |
| Total cost of treatments | measured through study completion, up to 2 years | measured based on total costs during length of hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Function | measured at discharge, 3 months, and 6 months, through study completion, up to 2 years | as measured by FVC (forced vital capacity), FEV1, and TLC by spirometry |
| Time to wean from ventilator | measured through study completion, up to 2 years | measured in days |
| Pain Control documented by the Functional Pain Scale | measured before and after surgery and at time of discharge, through study completion, up to 2 years | measured using the Functional Pain Scale |
| Complication Rates | measured at 1 week, 3 months, 6 months | including, but not limited to, pneumonia, urinary tract infection, arrhythmia, sepsis, reintubation, wound infection |
| Tracheostomy rates | measured at 1 week, 3 months, 6 months | overall rate of tracheostomy in population |
| Ventilator/Ventilator Free Days | measured through study completion, up to 2 years | measured in days on or off ventilation, based on length of stay in hospital |
| Narcotic usage | measured at 1 week, 3 months, 6 months | converted to units of morphine |
| Hospital length of stay | measured through study completion, up to 2 years | measured in days |
Countries
United States
Contacts
Primary ContactDonna Nayduch, RN, MSN
Outcome results
None listed