NCT00292097终止不适用
A Prospective, Randomized Trial of Early Versus Conventional Conversion From Endotracheal Intubation to Percutaneous Tracheostomy for Ventilatory Support of Trauma Patients With Severe Brain Injury
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Total number of mechanical ventilation days
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (ET) to percutaneous, dilatational tracheostomy (PDT) in traumatic brain-injured patients requiring prolonged mechanical ventilation.
详细描述
This is a prospective, randomized trial to evaluate the efficacy of early (less than or equal to 72 hours) versus late (10 to 14 days) conversion from endotracheal intubation to percutaneous, dilatational, translaryngeal tracheostomy for mechanical ventilation of traumatic brain injured patients.
The primary efficacy parameter will be the number of days on mechanical ventilation.
Secondary objectives include:
- Number of days in the hospital
- To assess the incidence of ventilator-acquired pneumonia in each group
- To assess the incidence of accidental extubation in each group
- To assess the incidence of death in each group
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •TBI defined as penetrating or blunt brain injury including 1)subarachnoid hemorrhage, 2)subdural hemorrhage, 3) epidural hemorrhage, 4)brain contusion, 5)diffuse axonal injury
- •mechanically ventilated by endotracheal intubation
- •projected to need ventilation support for more than 14 days according to: GCS measured in field less than or equal to 8 and a GCS on day 3 which remains less than or equal to 8
- •informed consent obtained from patient or legal representative
排除标准
- •less than 18 years of age
- •projected to need ventilation support for less than 14 days
- •anatomical deformity of the neck, including thyromegaly and cervical tumors
- •previous tracheostomy
- •uncontrolled coagulopathy
- •existence of platelet count less than 50,000/mm2
- •anti-platelet agents
- •clinical evidence of ongoing infection at the proposed tracheostomy site as per physician
- •mechanical ventilation with a positive end-expiratory pressure greater than 12 cm H20
- •intubated more than 72 hours
- •patient has undergone cricothyroidotomy
- •cricoid cartilage, trachea, or sternal notch not palpable with neck in position
结局指标
主要结局
Total number of mechanical ventilation days
时间窗: until discharged
次要结局
- Total number of hospital days(until discharged)
- Incidence of ventilator-associated pneumonia(until discharged)
- Incidence of accidental extubation(until discharged)
- Incidence of death(until discharged)
研究者
研究点 (2)
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