A Multi Centered Randomized Controlled Trial of Operative Versus Non-operative Treatment of Acute, Unstable Chest Wall Injuries
试验速览
- 阶段
- 不适用
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Ventilator-free days (VFD)
研究概览
简要总结
Unstable chest injuries are common in poly trauma patients. They can lead to severe pulmonary restriction, loss of lung volume, difficulty with ventilation and can render the patient to require intubation and mechanical ventilation. Traditionally these injuries have been treated non-operatively, however in the past decade there has been numerous studies suggesting improved outcomes with surgical fixation. Surgical fixation can significantly decrease time spent in ICU as well as day on mechanical ventilation. The investigators aim is to conduct a randomized control trial of these injuries, to compare non-operative treatment with surgical fixation. The investigators' hypothesis is that surgically treated patient will have significantly improved outcomes compared to those treated non-operatively.
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 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >16 or skeletal maturity
- •Meeting one of the two indication for surgical fixation of chest wall injury:
- •Flail chest, defined as follows:
- •3 unilateral segmental rib fractures; OR
- •3 bilateral rib fractures; OR
- •3 unilateral fractures combined with sternum fracture/dissociation Note: at least 3 of the rib fractures involved in the flail segment must demonstrate displacement.
- •Severe deformity of the chest wall (Diagnosed by CT scan). Defined as follows:
- •Severe (100%) displacement of 3 or more ribs OR
- •Marked loss thoracic volume/caved in chest (>25% volume loss in involved lobe(s)); OR
- •Overriding of 3 or more rib fractures (by minimum 15mm each); OR
- •Two or more rib fractures associated with intra-parenchymal injury - ie ribs in the lung, in the parenchyma
排除标准
- •Anatomic location of rib fractures are not amenable to surgical fixation (eg fractures directly adjacent to spinal column)
- •Rib fractures primarily involving floating ribs (ribs 10-12)
- •Home Oxygen (O2) requirement
- •Other significant injuries that may require long term intubation:
- •Severe pulmonary contusion (Defined as PaO2/FIO2 ratio <200 with radiological evidence of pulmonary infiltrates WITHIN 24 hours of THORACIC TRAUMA)
- •Severe head injury/Traumatic brain injury - (GCS ≤ 8 at 48 hrs post injury. If unable to assess full GCS due to intubation or other causes, GCS motor ≤4 at 48 hrs post injury)
- •Upper airway injury requiring long term intubation and mechanical ventilation (e.g. tracheal disruption)
- •Acute quadriplegia/quadraparesis
- •Head and neck burn injuries, or inhalation burn injuries
- •Dementia or other inability to complete follow-up questionnaires
- •Medically unstable for OR (e.g. haemodynamic instability, acidosis, coagulopathy, etc.)* or unlikely to survive 1 year follow-up, in the opinion of the attending physician
- •Lack of informed consent from patient or substitute decision maker
- •Randomization > 72 hours from injury
- •ORIF > 96 hours from injury (if randomized to surgical fixation group)
- •Age > 85
结局指标
主要结局
Ventilator-free days (VFD)
时间窗: 28 Days
To compare early surgical fixation versus conventional, non-surgical treatment of unstable chest injuries on the basis of our primary outcome measure of days spent free from a mechanical ventilator in the first 28 days following injury.
次要结局
- Number of days in the Intensive Care Unit (ICU)(12 months)
- Rate of Pneumonia(12 months)
- Amount of pain medication administration, converted to oral morphine equivalence(4 weeks)
- Pulmonary function assessment(12 months)
- Rate of return to work(12 months)
- assessment of functional health and well being(12 months)