A Multicenter Prospective Randomized Trial on the Intervention of Rib Fixation for Clinically Severe Rib Fractures From Trauma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 236
- 试验地点
- 20
- 主要终点
- ICU Length of Stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
ICU Length of Stay
时间窗: measured through study completion, up to 2 years
length of stay in days
次要结局
- 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)
研究者
Darwin Ang
Director, Medical Trauma Services, Ocala Health Trauma
SCRI Development Innovations, LLC