NCT04081233已完成不适用
The Effect of Early Stabilization of Rib Fractures on Patient-Centered Outcomes: A Randomized Clinical Trial
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2020年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Hospital Length of Stay
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Hospital Length of Stay
时间窗: 180 days after admission
Number of days patient is in the hospital
次要结局
- Incidence of Respiratory Failure Requiring Mechanical Ventilation Greater Than 24 Hours(24 hours after hospital admission)
- Opioid Usage(Hospital discharge (about 20 to 30 days))
- Time From Injury to Return to Work(180 days post admission)
- Number of Patients Requiring Tracheostomy(Hospital discharge (about 20 to 30 days))
- Number of Patients Who Developed Pneumonia During the Hospitalization(6 months after admission)
- Health Status as Indicated by Level of Impairment as Assessed by the Euroqol-5D-5L(180 days post admission)
- Number of Patients Who Received Regional Analgesia(6 months after admission)
- Ventilator Free Days(Hospital discharge (about 20 to 30 days))
- Re-intervention Rates for Surgical Complications(180 days post admission)
- Time From Injury to Resolution of Pain(180 days post admission)
- Mortality(180 days after admission)
- Intensive Care Unit (ICU) Free Days(Hospital discharge (about 20 to 30 days))
- Hospital (ICU) Free Days(30 days post admission)
- Health Status as Assessed by Visual Analog Scale (VAS) Score on the Euro Quality of Life Questionnaire (Euro QoL 5-D 5-L)(180 days post admission)
- Health Status as Assessed by Index Score on the Euroqol-5D-5L(180 days post admission)
- Time From Injury to Return to Usual Activity(180 days post admission)
- Number of Participants Prescribed Opioids at Discharge(Hospital discharge (about 20 to 30 days))
- Number of Participants Back to Work or Normal Physical Activity(180 days post admission)
研究者
David E. Meyer, MD, MS, FACS
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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