Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care
研究概览
简要总结
Background:
One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy). As shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage location, presence of intraventricular hemorrhage (IVH), and occlusive hydrocephalus as well as presence of COPD (Huttner HB et al 2006 CVD).
Sustained restricted vigilance and impaired consciousness after ICH is likely to result in failure of extubation, raise in incidence of ventilator-associated pneumonia, increased amount of sedative drugs and prolonged duration of neurocritical care.
Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical ventilation.
Basic hypothesis:
Compared to patients with conventional ("late") tracheostomy between day 12 - 14, patients with "early" tracheostomy within 72h after admission will have:
- shorter cumulative time of mechanical ventilation
- less incidence of ventilator-associated pneumonia
- less consumption of sedative drugs
- shorter duration of stay in neurocritical care unit
Randomization:
Consecutive eligible patients are randomly assigned to Either "early" tracheostomy within 72h after hospital admission Or "late" tracheostomy (= control group; undergoing conventional tracheostomy between day 12 - 14 if extubation fails) Both groups receive plastic tracheostomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring intubation / mechanical ventilation
- •Supratentorial intracerebral hemorrhage (including:)
- •primary spontaneous ICH (lobar / deep)
- •ICH related to anticoagulant therapy
- •with or without intraventricular hemorrhage
- •with or without occlusive and / or communicating hydrocephalus
- •Hematoma volume >0 ml and <60 ml
- •Age 18 - 85 years
- •Informed consent (legal representative)
排除标准
- •Patients with elective intubation/ventilation for EVD placement
- •Patients with "do not treat" / "do not resuscitate" orders, severe co- morbidity and life expectancy of less than 3 months
- •Absent consent of relatives for invasive (neuro-)critical care
- •Contraindication for tracheostomy
- •Other than primary supratentorial ICH or supratentorial ICH related to oral anticoagulants
- •Pre-existing COPD (known/treated)
- •Pre-existing congestive heart failure (≥3 NYHA)
- •Pre-existing modified Rankin Scale (≥4)
结局指标
主要结局
Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care
时间窗: 30 days
Primary End-points: * Cumulative time requiring mechanical ventilation * Overall duration of neurocritical care
次要结局
- 3-months functional outcome (mRS)(90 days)
- Cumulative consumption of sedative drugs(30 days)
- Incidence of respirator-associated pneumonia(30 days)
- In-hospital mortality(30 days)
- Incidence of episodes with increased intracranial pressure(30 days)