The NEUROlogically-impaired Extubation Timing Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 试验地点
- 26
- 主要终点
- ICU Free Days
研究概览
简要总结
This randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness. It will directly compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed according to physicians' discretion. The primary outcome will be ICU free days (days spent alive and outside an ICU).
详细描述
Thousands of patients suffer severe brain injuries every year, from causes such as trauma, stroke, and infection. Extensive clinical research in weaning from mechanical ventilation has led to recommendations for prompt extubation following a successful trial of spontaneous breathing in general intensive care unit (ICU). However, little evidence exists to guide decisions about when to remove the breathing tube in patients with severe brain injury. It is unclear which of the following strategies would optimize important patient outcomes: prompt extubation vs. waiting and extubating or performing a tracheostomy, timed according to physicians' discretion. Each strategy has associated risks: prompt extubation may lead to higher rates of extubation failure and reintubation, whereas waiting longer may expose patients to complications from prolonged mechanical ventilation and tracheostomy may lead to procedural complications (or unnecessary procedures, if prompt extubation would be successful). This trial in brain-injured patients will test which of the following will lead to better patient outcomes: (1) removing the endotracheal tube promptly once a spontaneous breathing trial is passed; or (2) usual care, with the airway management strategy selected according to the preference of the treating physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Age > 16 years
- •Acute brain injury (subarachnoid hemorrhage, ischemic stroke, spontaneous intracerebral hemorrhage, seizure, traumatic brain injury, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis/cerebral abscess) that occurred within the previous 4 weeks.
- •Receiving invasive mechanical ventilation via endotracheal tube for > 72 hours
- •Glasgow Coma Scale motor score 3 to 6 with improvement or no change from previous day
- •passed spontaneous breathing trial (SBT)
排除标准
- •Previous extubation during this ICU admission
- •Quadriplegic
- •Neuromuscular disease that will result in prolong need for mechanical ventilation, including but not limited to Guillain-Barre syndrome, cervical spinal cord injury, advanced multiple sclerosis
- •Do-Not-Reintubate order in place
- •Previously randomized in this trial
- •Underlying pre-existing condition with expected mortality less than 6-months.
- •Anticipated/scheduled for surgical procedures within 48 hours
- •C-spine not yet cleared for activity as tolerated (cleared for activity as tolerated while wearing hard collar is acceptable)
- •Currently known or suspected to have an difficult airway
- •Absence of an endotracheal tube cuff leak, if checked
- •Absence of spontaneous or induced cough
- •Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
结局指标
主要结局
ICU Free Days
时间窗: 60 days
The primary outcome is number of ICU free days to day 60, defined as the number of days spent alive and outside of an ICU until day 60. The primary outcome will be measured to answer the following primary question: Among patients receiving minimal mechanical ventilatory support for severe and persistent brain injury, which of the following airway management strategies increase ICU-free days to day 60: (1) prompt extubation vs. (2) usual care, which may include extubation or tracheostomy timed according to physicians' discretion?
次要结局
- Antibiotic Days(up to day 14)
- Rate of Tracheostomy Insertion(up to 6 months)
- Hospital Discharge Destination(at hospital discharge)
- Extended Glasgow Outcome Score(up to 6 months)
- EQ-5D(up to 6 months)
- Nutrition Intake(up to 6 months)
- Rate of ICU Readmission(up to hospital discharge)
- Airway Complications(up to 60 days)
- Delirium(up to day 14)
- Mortality,(up to 6 months)
- Ventilator-Free Days(up to 60 days)
研究者
Dr. Damon Scales
MD, PhD, FRCPC
Sunnybrook Health Sciences Centre