Stroke-Related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical Care Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Intensive Care Unit Length of Stay (ICU-LOS)
研究概览
简要总结
Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. This study investigates the potential benefits of early tracheostomy in ventilated critically ill patients with ischemic or hemorrhagic stroke.
详细描述
Background: Tracheostomy is a common procedure in critical care patients. Advantages of a short tracheal tube compared to a long orotracheal one are the avoidance of laryngeal lesions and sinusitis, facilitation of nursing care and physiotherapy and the reduction of analgosedatives. The optimal point in time for tracheostomy is still unknown, but it is commonly done not later than 2-3 weeks and after one or several failed extubation trials. Studies in different sets of critical care patients have suggested additional advantages of early tracheostomy: less pneumonias and other complications, more patient comfort, less analgosedation, shorter duration of ventilation and of ICU stay. These questions have not been looked at in non-traumatic neurocritical care patients, although these might have a special weaning benefit by early tracheostomy, being mainly compromised in securing their airway, but not in breathing.
Method: Non-traumatic Neurocritical care patients with ischemic strokes, intracerebral hemorrhage or subarachnoid hemorrhage so severly affected that 2 weeks of ventilation need are estimated, are principally eligible for the study. After randomization, one group receives tracheostomy within the first 3 days after intubation. The other group stays orotracheally intubated and is either weaned and extubated or receives tracheostomy within 7 to 14 days after intubation. Tracheostomy is done as percutaneous dilatation by neurologists.
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
- •age > 18 years
- •informed consent from legal representative
- •non-traumatic cerebrovascular disease
- •Estimated ventilation need for at least 2 weeks
排除标准
- •age < 18 years
- •informed consent not obtainable
- •intubated for more than 3 days
- •death within 3 weeks likely
- •severe chronic pulmonary disease
- •severe chronic cardiac disease
- •emergency situation
- •intracranial pressure difficult to control
- •need for a permanent tracheostoma
- •contraindications for dilatative tracheostomy
- •severe coagulopathy
- •severe respiration difficulties
- •intubation/extubation/tube exchange difficulties
结局指标
主要结局
Intensive Care Unit Length of Stay (ICU-LOS)
时间窗: open
The primary endpoint is assessed as days from admission to until discharge from the intensive care unit.
次要结局
- Duration of Ventilation(open)
- Duration and Quality of Weaning(Within ventilation time)
- Time of ICU-dependence(open)
- Vasopressor Dependence(within ICU-LOS)
- Time of Antibiotic Treatment(within ICU-LOS)
- Pneumonias(within ICU-LOS)
- Occurrence and Duration of Sepsis(within ICU-LOS)
- Number and type of complications associated with the procedure(10 days post tracheostomy)
- Cost of Treatment(within ICU-LOS)
- Functional Outcome(admission, discharge, at 6 months)
- Mortality(during stay, after 6 months)
- Hospital Length of Stay(open)
- Time of Analgosedation Dependence(within ICU-LOS)
研究者
Julian Boesel
PD Dr.med., Attending Neurology, Director NCCU
Heidelberg University