A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rib Fracture
- Sponsor
- Darwin Ang
- Enrollment
- 236
- Locations
- 10
- Primary Endpoint
- ICU Length of Stay
- Last Updated
- 3 years ago
Overview
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.
Investigators
Darwin Ang
Director, Medical Trauma Services, Ocala Health Trauma
SCRI Development Innovations, LLC
Eligibility Criteria
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
Outcomes
Primary Outcomes
ICU Length of Stay
Time Frame: measured through study completion, up to 2 years
length of stay in days
Secondary Outcomes
- Quality of Life, as determined by SF-36 survey(measured at 1 week, 3 months, 6 months post-intervention)
- Number of participants with pneumonia as defined by the Centers for Disease Control(measured monthly through course of study, up to 2 years)
- Total cost of treatments(measured through study completion, up to 2 years)