A Prospective Trial of Elective Extubation in Brain Injured Patients Meeting Extubation Criteria for Ventilatory Support.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Modified Rankin Score
研究概览
简要总结
Identifying the optimal time of extubation in a brain injured population should improve patient outcome. Brain injured patients usually remain intubated due to concerns of airway maintenance. Current practice argues that unconscious patients need to remain intubated to protect their airways. More recent data however suggests that delaying extubation in this population increases pneumonias and worsens patient outcomes.
We designed a safety and feasibility study of randomizing brain injured patients into early or delayed extubation. The purpose was to gain insight into patient safety concerns and to obtain estimates of sample size needed for a larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Resolution or improvement of any pulmonary process requiring mechanical ventilation.
- •Adequate gas exchange.
- •Adequate ventilation.
- •Respiratory rate to tidal volume ratio <
- •Core body temperature < 38 degrees celsius.
- •Hemoglobin > 8 grams per deciliter.
- •No sedative medications for 2 hours.
- •Neurological requirements included:
- •Intracranial pressure (ICP) < 15 cm of water and a cerebral perfusion pressure (CPP) > 60 mm Hg for patients with intracranial pressure monitors.
排除标准
- •Age < 18 years.
- •Lack of informed consent by the patients' surrogate.
- •Dependence on mechanical ventilation for at least two weeks prior to enrollment.
- •Patients with tracheostomies.
- •Intubation instituted for therapeutic hyperventilation.
- •Planned surgical or radiological intervention within the next 72 hours.
- •Anticipated neurological or medically worsening conditions (i.e develop cerebral edema or vasospasm).
- •Patients intubated for airway preservation due to airway edema (cervical neck injuries or surgery) as opposed to airway protection.
研究组 & 干预措施
armA I
Patients remain intubated until the patients Glasgow coma score improves to greater than 8.
干预措施: continued intubation (Procedure)
arm 2
Patients that meet standard airway and ventilatory criteria for extubation but have a Glasgow coma score of less than or equal to 8 are immediately extubated.
干预措施: extubation (Procedure)
结局指标
主要结局
Modified Rankin Score
时间窗: 6 months
次要结局
- reintubations(hospital discharge)
- ICU length of stay(hospital discharge)
- nosocomial pneumonias(hospital discharge)
- hospital length of stay(hospital discharge)